MedWorm: Food and Drug Administration (FDA)

A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data. - Walkup JT, Townsend L, Crystal S, Olfson M.

SafetyLit: All (Unduplicated) — Thu, 09 Feb 2012 12:09:27 +0100

PURPOSE: As part of the Mini-Sentinel pilot program, under contract with the Food and Drug Administration, an effort has been made to evaluate the validity of algorithms useful for identifying health outcomes of interest, including suicide and suicide atte... (Source: SafetyLit: All (Unduplicated))

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Proton Pump Inhibitors Raise Persistent Diarrhea Risk, Warns FDA

Health News from Medical News Today — Wed, 08 Feb 2012 23:00:00 +0100

Stomach acid drugs, known as PPIs (proton pump inhibitors), are linked to a higher risk of diarrhea caused by Clostridium difficile, a type of bacterium. Patients on PPIs who develop persistent diarrhea should be tested for CDAD (Clostridium difficile associated diarrhea), says the US Food and Drug Administration (FDA). If you are taking PPIs, and have diarrhea that does not go away, you should see your doctor immediately, the FDA advises... (Source: Health News from Medical News Today)

Deep brain stimulation enhances spatial memory

Guardian Unlimited Science — Wed, 08 Feb 2012 22:46:00 +0100

A small study shows that direct electrical stimulation of the entorhinal cortex enhances performance on a spatial memory taskDirect electrical stimulation of a specific part of the brain can enhance spatial memory in conscious neurosurgical patients, according to a small new study published in the New England Journal of Medicine. The research suggests that an experimental technique called deep brain stimulation could help patients with memory impairments, such as those with Alzheimer's disease. Deep brain stimulation (DBS) is a surgical technique involving the implantation of thin wire electrodes into the brain. In 2002, the U.S. Food and Drug Administration approved the technique as a treatment for Parkinson's Disease, and more recently, a number of clinical trials have shown that it effe...

Consumers want tougher probe of engineered salmon

Reuters: Health — Wed, 08 Feb 2012 16:27:12 +0100

WASHINGTON (Reuters) - Three consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat. (Source: Reuters: Health)

FDA Will Speed Up Review of Roche Cancer Drug

Drugs.com - Pharma News — Wed, 08 Feb 2012 12:02:22 +0100

From Associated Press (February 7, 2012) NEW YORK -- Swiss drugmaker Roche said Tuesday that the Food and Drug Administration will make a decision on its experimental breast cancer drug pertuzumab by June. Roche's Genentech business aid the... (Source: Drugs.com - Pharma News)

Merck provides suvorexant insomnia update

Pharmacy Europe — Wed, 08 Feb 2012 10:50:00 +0100

Merck plans to file a new drug application with the US Food and Drug Administration in 2012 (Source: Pharmacy Europe)

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FDA grants Roche's pertuzumab Priority Review for previously untreated HER2-positive metastatic breast cancer

Roche Media News — Wed, 08 Feb 2012 06:00:00 +0100

Roche today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application for pertuzumab and granted Priority Review. (Source: Roche Media News)

Stimulant treatment for ADHD not associated with increased risk of cardiac events in youth

EurekAlert! - Social and Behavioral Science — Wed, 08 Feb 2012 05:00:00 +0100

(Elsevier) Attention-deficit/hyperactivity disorder (ADHD) affects 5-9% of youth and is frequently treated with stimulant medications, such as methylphenidate and amphetamine products. A recent safety communication from the US Food and Drug Administration advised that all patients undergoing ADHD treatment be monitored for changes in heart rate or blood pressure. (Source: EurekAlert! - Social and Behavioral Science)

Horizon scanning: FDA approves VyvanseT (lisdexamfetamine dimesylate) for maintenance of ADHD in adults

NeLM - News — Wed, 08 Feb 2012 05:00:00 +0100

Source: BioSpace Area: News The US Food and Drug Administration (FDA) has approved Vyvanse® (lisdexamfetamine dimesylate) capsules for the maintenance treatment of adults with Attention-Deficit/Hyperactivity Disorder (ADHD). This new approval is additional to the indication for Vyvanse as a treatment for ADHD in patients aged 6 years and above. The approval is based on results from a six-week phase IV, double-blind, multi-centre, placebo-controlled, randomized withdrawal design study which assessed the maintenance of efficacy and safety of Vyvanse in 123 adults who met DSM-IV-TR® criteria for ADHD. Following an open-label treatment, in which patients continued to receive the same Vyvanse dose they were taking at study entry, those who maintained treatment re...

Horizon scanning: FDA approves SkliceT (ivermectin) Lotion for the treatment of head lice

NeLM - News — Wed, 08 Feb 2012 05:00:00 +0100

Source: PharmaLive Area: News According to a Pharmalive report, the U.S. Food and Drug Administration (FDA) has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. The treatment involves a single 10-minute application without nit combing. The approval was based on results of two randomized, double-blind phase III clinical trials that compared Sklice Lotion with a vehicle control (placebo) in 781 patients from the United States who were 6 months of age and older. More subjects in the treatment group were louse-free without any nit combing after two weeks and less than 1% of patients experienced adverse events, which included conjunctivitis, ocular hyperaemia, eye irritation, dandruff, dry skin and skin-...

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Horizon scanning: FDA Grants priority review of crofelemer for diarrhoea in patients with HIV/AIDS on anti-retroviral therapy

NeLM - News — Wed, 08 Feb 2012 05:00:00 +0100

Source: BioSpace Area: News According to a Biospace report, the U.S. Food and Drug Administration (FDA) has granted Priority Review for crofelemer 125 mg tablets for the control and symptomatic relief of diarrhoea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy. (Source: NeLM - News)

Horizon scanning: FDA Grants priority review of pertuzumab for untreated HER2-Positive metastatic breast cancer

NeLM - News — Wed, 08 Feb 2012 05:00:00 +0100

Source: BioSpace Area: News According to a Biospace report, the U.S. Food and Drug Administration (FDA) has granted Priority Review for pertuzumab in combination with trastuzumab and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy. (Source: NeLM - News)

Horizon scanning: AmiKetT for peripheral neuropathic pain filed for FDA fast track designation

NeLM - News — Wed, 08 Feb 2012 05:00:00 +0100

Source: BioSpace Area: News According to a Biospace report, EpiCept has filed AmiKetT (amitriptyline 4%, ketamine 2% cream) for Fast Track designation with the U.S. Food and Drug Administration (FDA). AmiKetT is a prescription topical cream under late stage clinical development by EpiCept for the treatment of chemotherapy-induced peripheral neuropathic pain. (Source: NeLM - News)

IV acetaminophen potential source of pediatric dosing errors

The Poison Review — Wed, 08 Feb 2012 03:49:22 +0100

4 out of 5 stars Intravenous Acetaminophen in the United States: Iatrogenic Dosing Errors. Dart RC, Rumack BH. Pediatrics 2012;129:349-353. Abstract Recently, the US Food and Drug Administration approved the use of intravenous acetaminophen (Ofirmev, Cadence Pharmaceuticals) for the treatment of pain and/or fever. Although the product was not approved for use in children less than 2 years of age, off-label use in this population is likely. One source of iatrogenic overdosing — reported during the drug’s extensive use in Europe – is dose calculation error in young children. This involves calculating the dose in milligrams, but administering that number of milliliters. Since the formulation in 10 mg/ml, this produces a 10-fold error. Although these events appear to be rar...

Consumer groups want tougher probe of engineered salmon

Reuters: Health — Wed, 08 Feb 2012 02:49:16 +0100

WASHINGTON (Reuters) - Three U.S. consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat. (Source: Reuters: Health)

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The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines.

Cancer Imaging — Wed, 08 Feb 2012 00:30:02 +0100

Authors: Gold LS, Klein G, Carr L, Kessler L, Sullivan SD Abstract In this article, we trace the chronology of developments in breast imaging technologies that are used for diagnosis and staging of breast cancer, including mammography, ultrasonography, magnetic resonance imaging, computed tomography, and positron emission tomography. We explore factors that affected clinical acceptance and utilization of these technologies from discovery to clinical use, including milestones in peer-reviewed publication, US Food and Drug Administration approval, reimbursement by payers, and adoption into clinical guidelines. The factors driving utilization of new imaging technologies are mainly driven by regulatory approval and reimbursement by payers rather than evidence that they provide benefits...

EpiCept files fast track status for AmiKet

Drug Development Technology — Wed, 08 Feb 2012 00:00:00 +0100

EpiCept Corporation has filed a fast track designation with the US Food and Drug Administration (FDA) for its AmiKet, used for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). (Source: Drug Development Technology)

Sanofi head-lice lotion wins FDA approval

Reuters: Health — Tue, 07 Feb 2012 21:07:21 +0100

PARIS (Reuters) - Sanofi said on Tuesday that the Food and Drug Administration had approved a lotion to treat head lice after clinical trials, which compared it with a placebo. (Source: Reuters: Health)

Sanofi Announces FDA Approval of Sklice Lotion for the Treatment of Head Lice

Drugs.com - New Drug Approvals — Tue, 07 Feb 2012 20:02:45 +0100

BRIDGEWATER, N.J., Feb. 7, 2012 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older.... (Source: Drugs.com - New Drug Approvals)

The comparative research on constituents of Radix Aconiti and its processing by HPLC quadrupole TOF-MS.

Biomedical Chromatography : BMC — Tue, 07 Feb 2012 05:00:00 +0100

Authors: Wu J, Hong B, Wang J, Wang X, Niu S, Zhao C Abstract Based upon the regulations stipulated by the State Food and Drug Administration of China, only the processed, detoxified tubers and roots of Aconitum are allowed to be administered orally, used in clinical decoctions and adopted as raw materials for pharmaceutical manufacturing, so the processing principle of preparation of Radix Aconiti is important for ensuring the Radix Aconiti praeparata quality. A simple approach was described for HPLC-Q-TOF-MS screening and identification of many of the aconitine alkaloids present in unprocessed Radix Aconiti and Radix Aconiti praeparata. To compare their fingerprints, the processing principle of preparation of Radix Aconiti was developed. Twenty-nine compounds and 26 compounds wer...

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Ziopharm oral Palifosfamide gets FDA IND approval

Drug Development Technology — Tue, 07 Feb 2012 00:00:00 +0100

The US Food and Drug Administration (FDA) has accepted the investigational new drug application for Ziopharm Oncology's oral Palifosfamide (Zymafos or ZIO-201), which is used as a treatment for metastatic soft tissue sarcoma. (Source: Drug Development Technology)

FDA staff unsure about new use for Amgen's Xgeva

Reuters: Health — Mon, 06 Feb 2012 22:08:40 +0100

WASHINGTON (Reuters) - Reviewers from Food and Drug Administration said they were not sure whether Amgen Inc's Xgeva bone drug should be also approved as a treatment to delay the spread of cancer to the bone. (Source: Reuters: Health)

North American Rescue, LLC Announces A Follow-Up to the Recall of Crickit Convenience Kits Because of Possible Health Risk Related to Nationwide Recall of Triad Povidone Iodine Prep Pads

Food and Drug Administration — Mon, 06 Feb 2012 21:32:00 +0100

Under the direction of the FDA, North American Rescue, LLC (NAR) today announces the market recall of the NAR Surgical Crichothyroidotomy Kit or Crickit, due to potential contamination of the povidone iodine prep pads, manufactured by Triad Group. This recall is a follow up to the recall initiated on May 5, 2011. North American Rescue, LLC has successfully contacted 97% of our customers and requested they contact our customer service department for return instructions. (Source: Food and Drug Administration)

FDA staff unsure about new use for Amgen's Xgeva

Reuters: Health — Mon, 06 Feb 2012 15:18:07 +0100

WASHINGTON (Reuters) - Reviewers from the U.S. Food and Drug Administration said on Monday that they were not sure whether Amgen Inc's Xgeva bone drug should be approved for a wider use of delaying the spread of cancer to the bone. (Source: Reuters: Health)

While government discredits raw milk, it keeps names of salmonella outbreak restaurants secret to protect corporate profits

NaturalNews.com — Mon, 06 Feb 2012 06:00:00 +0100

The U.S. Food and Drug Administration (FDA) is getting increasingly bold these days with openly admitting that it works directly for big industry interests rather than public health interests. In a recent report on why the agency did not disclose Taco Bell as being the... (Source: NaturalNews.com)

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E. Coli O157:H7 Population Reduction from Alfalfa Seeds with Malic Acid and Thiamine Dilauryl Sulfate and Quality Evaluation of the Resulting Sprouts

Journal of Food Science — Mon, 06 Feb 2012 05:00:00 +0100

The objectives of this research were to examine the efficacy of malic acid (MA) and thiamine dilauryl sulfate (TDS) combined treatments on the inactivation of E. coli O157:H7 on alfalfa seeds, to study the growth of the remaining E. coli cells during sprouting, and to evaluate the sprout quality. When 10 g of inoculated alfalfa seeds were washed in a 10% MA‐1% TDS solution, a complete elimination of E. coli was achieved. The same result was observed by washing the seeds in a 20000 ppm Ca(OCl)2 solution. However, when the seed size was increased to 50 g while maintaining the same seed‐to‐sanitizer ratio, both the MA + TDS and the 20000 ppm chlorine washes failed to completely inactivate the E. coli cells on the seeds. Nevertheless, the 10% MA‐1% TDS solution was significantly more e...

US FDA approves ivacaftor for treatment of rare form of cystic fibrosis

MedWire News - Respiratory — Mon, 06 Feb 2012 00:00:00 +0100

The US Food and Drug Administration has approved ivacaftor for treatment of cystic fibrosis in children aged 6 years or older with the G551D Cystic Fibrosis Transmembrane Regulator gene mutation. (Source: MedWire News - Respiratory)

Immunology in clinic review series; focus on autoinflammatory diseases: update on monogenic autoinflammatory diseases: the role of interleukin (IL)-1 and an emerging role for cytokines beyond IL-1.

Clinical and Developmental Immunology — Sun, 05 Feb 2012 16:27:15 +0100

Authors: Goldbach-Mansky R Abstract OTHER THEMES PUBLISHED IN THIS IMMUNOLOGY IN THE CLINIC REVIEW SERIES Allergy, Host Responses, Cancer, Type 1 diabetes and viruses, Metabolic diseases. SUMMARY: The disease-based discovery of the molecular basis for autoinflammatory diseases has led not only to a rapidly growing number of clinically and genetically identifiable disorders, but has unmantled key inflammatory pathways such as the potent role of the alarm cytokine interleukin (IL)-1 in human disease. Following its initial failures in the treatment of sepsis and the moderate success in the treatment of rheumatoid arthritis, IL-1 blocking therapies had a renaissance in the treatment of a number of autoinflammatory conditions, and IL-1 blocking therapies have been Food and Drug Administ...

Healthy People Co. Issues a Voluntary Recall of Specific Lots of the Dietary Supplements Found to Contain Undeclared Drug Ingredients

Food and Drug Administration — Sat, 04 Feb 2012 21:11:00 +0100

Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers. Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs. (Source: Food and Drug Administration)

Nest Collective Voluntarily Recalls Select Revolution Foods Jammy Sammy - Strawberry Jam & Peanut Butter Snack Size Sandwich Bars Due to a Labeling Error (Undeclared Peanut on Inner Wrapper)

Food and Drug Administration — Sat, 04 Feb 2012 17:47:00 +0100

Nest Collective ™ announced today that it is voluntarily recalling 8150 selling units of its Jammy Sammy™ - Strawberry Jam & Peanut Butter Flavor Snack Size Sandwich Bars due to a mislabeled inner wrapper. The cartons contain the best by date June 28, 2012 and are marked with the following universal product code (UPC) #89676600116 6 located on the bottom of the package. (Source: Food and Drug Administration)

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California Firm Recalls Prepared Sandwiches that Contain Hard-Cooked Eggs

Food and Drug Administration — Sat, 04 Feb 2012 04:48:00 +0100

GH Foods CA, LLC was notified by their supplier that the eggs supplied to them were from Michael Foods, Inc, who recalled Hard-Cooked eggs due to potential contamination by Listeria monocytogenes. GH Foods CA, LLC, Sacramento, California, is therefore recalling sandwiches, associated with the affected eggs, due to potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems. (Source: Food and Drug Administration)

Greencore, USA â€“ Cincinnati, Recalls Egg Salad Sandwiches with Brand Name Quick CafÃ© and Take Away CafÃ© because of Possible Health Risk

Food and Drug Administration — Fri, 03 Feb 2012 21:32:00 +0100

Greencore, USA is recalling approximately 550 pounds of egg salad sandwiches. The sandwiches contain eggs manufactured by Michael Foods Inc that are the subject of a previous recall due to possible contamination with Listeria Monocytogenes. (Source: Food and Drug Administration)

Talon leukemia drug gets date with FDA advisory panel

bizjournals.com Health Care:Biotechnology headlines — Fri, 03 Feb 2012 20:10:41 +0100

Talon Therapeutics Inc. must hurdle a Food and Drug Administration advisory panel March 21 before its experimental leukemia drug can be approved. San Mateo-based Talon (OTCBB: TLON) said Friday that its drug Marqibo will be assessed by the FDA’s oncology drugs advisory committee for treating adult Philadelphia chromosome-negative acute lymphoblastic leukemia, a rare blood cancer. “We believe Marqibo has the potential to help a near end-stage leukemia population of patients without good treatment options,” Talon President and CEO Dr... (Source: bizjournals.com Health Care:Biotechnology headlines)

Friday Report from GU ASCO; Biomarkers

Kidney Cancer Association — Fri, 03 Feb 2012 14:45:01 +0100

Ulka Vaishampayan, MD writes: Biomarkers represent the future of renal cancer therapeutics. With six new targeted-therapy agents receiving U.S. Food and Drug Administration approvals, and many more maturing toward becoming established therapies, optimization of these treatments has become a dire need of the moment. Current prognostic information is predominantly reliant on patient and tumor characteristics and is derived from basic clinical history, physical examination, and laboratory tests.02/04/2012 (Source: Kidney Cancer Association)

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Enforcement Report for February 1, 2012

Food and Drug Administration--Enforcement Report — Fri, 03 Feb 2012 14:10:00 +0100

(Source: Food and Drug Administration--Enforcement Report)

New device removes stroke-causing blood clots better than standard treatment

UCLA Newsroom: Health Sciences — Fri, 03 Feb 2012 14:00:00 +0100

An experimental device for removing blood clots in stroke patients dramatically outperformed the standard mechanical treatment, according to research presented by UCLA Stroke Center director Dr. Jeffrey L. Saver at the American Stroke Association's 2012 international conference in New Orleans on Feb. 3. The SOLITAIRE Flow Restoration Device is among an entirely new generation of devices designed to remove blood clots from blocked brain arteries in patients experiencing stroke. It has a self-expanding, stent-like design and, once inserted into a clot using a thin catheter tube, it compresses and traps the clot. The clot is then removed by withdrawing the device, thus reopening the blocked blood vessel. In the first U.S. clinical trial of SOLITAIRE, the device opened blocked ve...

Tainted juice saga reveals shocking truth about how much food we import

NaturalNews.com — Fri, 03 Feb 2012 06:00:00 +0100

Last month, the Coca-Cola Company notified the US Food and Drug Administration (FDA) that imported orange juice it uses in some of its drink products was found to be tainted with carbendazim, an illegal crop fungicide linked to infertility and testicular damage. Less... (Source: NaturalNews.com)

Allisonâ€™s Gourmet Kitchens Recalls Prepared Salads that Contain Hard Cooked Eggs Due to Potential Health Risk.

Food and Drug Administration — Fri, 03 Feb 2012 02:56:00 +0100

Allisonâ€™s Gourmet Kitchens was notified by their egg supplier, Michael Foods, Inc. that they are recalling numerous lots of their hard cooked eggs due to the potential for contamination by Listeria monocytogenes. Some of these eggs were introduced into our process to manufacture these effected products. (Source: Food and Drug Administration)

Vismodegib approved by US FDA for treatment of basal cell carcinoma

MedWire News - Oncology — Fri, 03 Feb 2012 00:00:00 +0100

The US Food and Drug Administration has approved vismodegib for treatment of metastatic basal cell carcinoma. (Source: MedWire News - Oncology)

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Merck receives FDA approval for Janumet

Pharmaceutical Technology — Fri, 03 Feb 2012 00:00:00 +0100

US-based pharmaceutical company Merck has received US Food and Drug Administration (FDA) approval for Janumet XR, its new type 2 diabetes treatment. (Source: Pharmaceutical Technology)

Prescriptions Blog: Drug Makers Dial Down TV Advertising

NYT Health — Thu, 02 Feb 2012 23:27:05 +0100

Pharmaceutical companies have cut spending on television advertising by 20 percent over the last five years, according to a Nielsen study. Analysts expect drug advertising to continue to fall as more brand-name drugs face generic competition. (Source: NYT Health)

Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093

Food and Drug Administration — Thu, 02 Feb 2012 22:20:00 +0100

Bedford Laboratories, today issues updated guidance on the following nationwide voluntary product recall originally initiated on December 20, 2011 (Source: Food and Drug Administration)

Wegmans Recalls Various Prepared Foods That Contain Hard-Cooked Eggs Produced by Michael Foods

Food and Drug Administration — Thu, 02 Feb 2012 21:23:00 +0100

Wegmans Food Markets, Inc. is recalling hard-cooked eggs, as well as prepared foods that contain hard-cooked eggs, sold between January 23 and February 1, 2012 because the eggs have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. (Source: Food and Drug Administration)

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S&M USA Enterprise Issues an Alert on Undeclared Sulfites in Zhang Zhou Brand Tremella

Food and Drug Administration — Thu, 02 Feb 2012 19:36:00 +0100

S&M USA ENTERPRISE is recalling ZHANG ZHOU BRAND TREMELLA because it may contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. (Source: Food and Drug Administration)

FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience

Drugs.com - New Drug Approvals — Thu, 02 Feb 2012 19:02:32 +0100

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Feb 2, 2012 - Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved Janumet XR (sitagliptin and metformin hydrochloride (HCl)... (Source: Drugs.com - New Drug Approvals)

Updated News Release With Corrected Lot Numbers: Advanced Animal Nutrition Recalls Dog Power Dry Dog Food

Food and Drug Administration — Thu, 02 Feb 2012 18:19:00 +0100

Advanced Animal Nutrition today announced a voluntary recall of its dry Dog Power Dog Food- due to aflatoxin levels that were detected above the acceptable limit. The affected products were manufactured between Jan. 4, 2011, and Nov. 18, 2011. (Source: Food and Drug Administration)

W & C International Import Inc. Issues An Alert On Un-Eviscerated "Rely" Dried Yellow Croaker

Food and Drug Administration — Thu, 02 Feb 2012 16:44:00 +0100

W & International Import Inc. is recalling "Rely" Dried Yellow Croaker because the product was found to be un-eviscerated. The recalled "Rely" Dried Yellow Croaker was distributed nationwide in bulk cardboard boxes. (Source: Food and Drug Administration)

W & C International Import Inc. Issues an Alert on Un-eviscerated â€œRelyâ€� Sardine Anchovies

Food and Drug Administration — Thu, 02 Feb 2012 16:41:00 +0100

W & International Import Inc. is recalling â€œRelyâ€� Sardine Anchovies because the product was found to be un-eviscerated. The recalled â€œRelyâ€� Sardine Anchovies were distributed nationwide in 7.0 oz. plastic packages.Â The â€œRelyâ€� Sardine Anchovies are a product of China. (Source: Food and Drug Administration)

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Medical Device Industry And FDA Reach Provisional Fees Agreement

Health News from Medical News Today — Thu, 02 Feb 2012 16:00:00 +0100

An agreement, in principle, regarding proposed recommendations for the new reauthorization of a medical device user fee program, has been agreed by the FDA and the Medical Device Industry. If the recommendations go through, the FDA would be authorized to collect $595 million from the medical device industry in user fees for a five-year period, with adjustments according to annual inflation rates. The FDA (Food and Drug Administration) says the fee structure will soon be finalized... (Source: Health News from Medical News Today)

New online databases help patients find adverse event

ICMCC: The International Council on Medical and Care Compunetics — Thu, 02 Feb 2012 14:44:49 +0100

Source: Sara Jackson, FierceHealthIT Content: “Two health IT startups aim to help patients sift through the reams of adverse event data collected by the U.S. Food and Drug Administration, according to a report today in the Wall Street Journal. The two companies, AdverseEvents and Clarimed, have developed websites backed by algorithms that sort FDA adverse event [...] (Source: ICMCC: The International Council on Medical and Care Compunetics)

Immunology in clinic review series; focus on autoinflammatory diseases: update on monogenic autoinflammatory diseases: the role of interleukin (IL)‐1 and an emerging role for cytokines beyond IL‐1

Clinical and Experimental Immunology — Thu, 02 Feb 2012 11:18:22 +0100

OTHER THEMES PUBLISHED IN THIS IMMUNOLOGY IN THE CLINIC REVIEW SERIESAllergy, Host Responses, Cancer, Type 1 diabetes and viruses, Metabolic diseases.SummaryThe disease‐based discovery of the molecular basis for autoinflammatory diseases has led not only to a rapidly growing number of clinically and genetically identifiable disorders, but has unmantled key inflammatory pathways such as the potent role of the alarm cytokine interleukin (IL)‐1 in human disease. Following its initial failures in the treatment of sepsis and the moderate success in the treatment of rheumatoid arthritis, IL‐1 blocking therapies had a renaissance in the treatment of a number of autoinflammatory conditions, and IL‐1 blocking therapies have been Food and Drug Administration (FDA)‐approved for the treatmen...

Mylan Receives Tentative FDA Approval For Generic Version Of Lipitor®

Pharmaceutical Online News — Thu, 02 Feb 2012 11:10:00 +0100

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base). (Source: Pharmaceutical Online News)

Bayer Initiates Expanded Access Program For Investigational Compound Radium-223 Chloride

Pharmaceutical Online News — Thu, 02 Feb 2012 11:00:00 +0100

Bayer HealthCare, LLC today announced that the U.S. Food and Drug Administration agreed that Bayer can proceed with its expanded access program to provide the investigational drug radium-223 chloride to patients diagnosed with castration-resistant prostate cancer (CRPC)/hormone-refractory prostate cancer (HRPC) with symptomatic bone metastases. (Source: Pharmaceutical Online News)

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Leading Medical Groups Collaborate To Ensure Consistent, Responsible Uptake Of Transcatheter Aortic Valve Replacement

Health News from Medical News Today — Thu, 02 Feb 2012 09:00:00 +0100

With the U.S. Food and Drug Administration's recent approval of transcatheter aortic valve replacement (TAVR) for patients with aortic valvular stenosis, the American College of Cardiology Foundation (ACCF), along with the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Thoracic Surgeons (STS), today released an expert consensus document to provide important guidance on its use... (Source: Health News from Medical News Today)

In Patients With Drug-Resistant Prostate Cancer, New Drug Extends Survival

Health News from Medical News Today — Thu, 02 Feb 2012 08:00:00 +0100

A new drug, MDV3100, is improving the survival rate in men with advanced prostate cancer, results of a large, phase III clinical trial show. The drug is designed to block a type of cellular receptor that drives progression of prostate cancer. Based on the strength of the data from the phase III trial, it is anticipated that the biopharmaceutical company Medivation, which licensed MDV3100, will file a new drug application with the Food and Drug Administration later this year... (Source: Health News from Medical News Today)

FDA clears Cynosure's cellulite-treating laser

Modern Medicine — Thu, 02 Feb 2012 05:00:00 +0100

The Food and Drug Administration has cleared Cynosure’s Cellulaze Workstation, a cellulite treatment device, for commercial distribution, the company announced. (Source: Modern Medicine)

Novartis Glivec wins extended FDA approval for three-year treatment

Drug Development Technology — Thu, 02 Feb 2012 00:00:00 +0100

The Novartis Glivec (imatinib) label has received an extended approval by the US Food and Drug Administration (FDA) to recommend 36 months of treatment for adult patients with KIT (CD117)-positive gastrointestinal stromal tumours (GIST). (Source: Drug Development Technology)

No need to loosen conflict rules, U.S. FDA head says

Reuters: Health — Wed, 01 Feb 2012 22:21:16 +0100

WASHINGTON (Reuters) - Congress should not loosen conflict of interest rules to expand the pool of potential U.S. government health advisers, the head of the Food and Drug Administration said on Wednesday. (Source: Reuters: Health)

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Michael Foods Recalls Hard-Cooked Eggs Packed In Brine Sold In 10- And 25-Pound Pails Because Of Possible Health Risk

Food and Drug Administration — Wed, 01 Feb 2012 21:16:00 +0100

Michael Foods, Inc. is recalling specific lot dates of hard-cooked eggs in brine sold in 10- and 25-pound pails for institutional use that were produced at its Wakefield, Nebraska facility because the product has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. (Source: Food and Drug Administration)

Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin

Drugs.com - New Drug Applications — Wed, 01 Feb 2012 21:02:29 +0100

SAN DIEGO, and WOODCLIFF LAKE, N.J., Feb. 1, 2012 /PRNewswire/ -- Arena Pharmaceuticals, Inc. and Eisai Inc. announced today that the US Food and Drug Administration (FDA) has notified Arena that an Endocrinologic and Metabolic Drugs... (Source: Drugs.com - New Drug Applications)

Toshiba gets FDA nod for Aquilion Prime CT

AuntMinnie.com Headlines — Wed, 01 Feb 2012 18:59:38 +0100

Toshiba America Medical Systems has received U.S. Food and Drug Administration (more) (Source: AuntMinnie.com Headlines)

Erivedge - Treatment For Most Common Form Of Skin Cancer

Health News from Medical News Today — Wed, 01 Feb 2012 17:00:00 +0100

Basal cell carcinoma is a form of skin cancer caused by regular sun exposure, or other ultraviolet radiation, which starts in the top layer of the skin (epidermis), is usually painless and grows slowly. The U.S. Food and Drug Administration just approved a new drug named Erivedge (vismodegib) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is designed for use in patients with locally advanced basal cell cancer, whose cancer has spread to other locations in the body, and who are unsuitable candidates for surgery or radiation... (Source: Health News from Medical News Today)

Scientists suing the FDA after covert surveillance

New Scientist - Health — Wed, 01 Feb 2012 15:06:00 +0100

US Food and Drug Administration alleged to have spied on scientists and doctors after they reported problems with approval of medical devices (Source: New Scientist - Health)

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FDA and industry reach agreement in principle on medical device user fees

Food and Drug Administration — Wed, 01 Feb 2012 14:48:00 +0100

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon. (Source: Food and Drug Administration)

FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes

Drugs.com - New Drug Approvals — Wed, 01 Feb 2012 13:02:34 +0100

RIDGEFIELD, Conn., and INDIANAPOLIS, Jan. 30, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin... (Source: Drugs.com - New Drug Approvals)

Amylin's long-delayed diabetes drug gets US nod (Associated Press, 28 January 2012)

Society for Endocrinology — Wed, 01 Feb 2012 12:00:00 +0100

The US Food and Drug Administration has approved the long-acting GLP-1 agonist Bydureon for the treatment of type 2 diabetes mellitus. Full article (Source: Society for Endocrinology)

F.D.A. Approves Cystic Fibrosis Drug

NYT — Wed, 01 Feb 2012 05:56:15 +0100

The Food and Drug Administration called Kalydeco a “breakthrough therapy” because it treats the underlying cause of the genetic disease, rather than just the symptoms. (Source: NYT)

FDA approves new skin cancer drug first tested in Arizona by Scottsdale Healthcare and TGen

EurekAlert! - Medicine and Health — Wed, 01 Feb 2012 05:00:00 +0100

(The Translational Genomics Research Institute) A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the US Food and Drug Administration, a remarkable accomplishment in new drug development. (Source: EurekAlert! - Medicine and Health)

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Ruxolitinib

Nature Reviews Drug Discovery — Wed, 01 Feb 2012 05:00:00 +0100

Authors: Ruben A. Mesa, Uma Yasothan & Peter Kirkpatrick In November 2011, ruxolitinib (Jakafi; Incyte/Novartis), a small-molecule inhibitor of Janus kinases, was approved by the US Food and Drug Administration for the treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythaemia vera myelofibrosis and post-essential thrombocythaemia myelofibrosis. (Source: Nature Reviews Drug Discovery)

FDA OKs ingenol mebutate for AK treatment

Modern Medicine — Wed, 01 Feb 2012 05:00:00 +0100

The Food and Drug Administration has approved Picato gel (ingenol mebutate, Leo Pharma) as a treatment for actinic keratoses on the face, scalp, trunk and extremities. (Source: Modern Medicine)

FDA approves vismodegib for basal cell cancers

Modern Medicine — Wed, 01 Feb 2012 05:00:00 +0100

The Food and Drug Administration has approved the groundbreaking, first-in-class drug Erivedge (vismodegib, Genentech) to treat adult patients with advanced and metastatic basal cell cancers. (Source: Modern Medicine)

Pediatric Analgesic Clinical Trial Designs, Measures, and Extrapolation: Report of an FDA Scientific Workshop

PEDIATRICS — Wed, 01 Feb 2012 05:00:00 +0100

Analgesic trials pose unique scientific, ethical, and practical challenges in pediatrics. Participants in a scientific workshop sponsored by the US Food and Drug Administration developed consensus on aspects of pediatric analgesic clinical trial design. The standard parallel-placebo analgesic trial design commonly used for adults has ethical and practical difficulties in pediatrics, due to the likelihood of subjects experiencing pain for extended periods of time. Immediate-rescue designs using opioid-sparing, rather than pain scores, as a primary outcome measure have been successfully used in pediatric analgesic efficacy trials. These designs maintain some of the scientific benefits of blinding, with some ethical and practical advantages over traditional designs. Preferred outcome measures...

President Global Corporation Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg

Food and Drug Administration — Wed, 01 Feb 2012 03:43:00 +0100

President Global Corp., Buena Park, CA is recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens. (Source: Food and Drug Administration)

Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets

Food and Drug Administration — Wed, 01 Feb 2012 02:52:00 +0100

Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market. (Source: Food and Drug Administration)

Funding bill may address drug shortages-aides

Reuters: Health — Wed, 01 Feb 2012 00:14:49 +0100

WASHINGTON (Reuters) - Legislation aimed at relieving shortages of crucial drugs used to treat cancer and other illnesses may get momentum next week when lawmakers decide whether to attach it to a must-pass funding bill for the U.S. Food and Drug Administration, congressional aides said on Tuesday. (Source: Reuters: Health)

Boehringer, Eli Lilly diabetes drug wins FDA nod

Drug Development Technology — Wed, 01 Feb 2012 00:00:00 +0100

Boehringer Ingelheim Pharmaceuticals and Eli Lilly have announced that the US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin / metformin hydrochloride) tablets, used for treating adults with type 2 diabetes. (Source: Drug Development Technology)

Roche’s skin cancer drug Erivedge given FDA nod

Pharmaceutical Technology — Wed, 01 Feb 2012 00:00:00 +0100

Roche’s skin cancer drug Eviredge, developed in collaboration with Curis, has been approved by the US Food and Drug Administration. (Source: Pharmaceutical Technology)

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FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer

Drugs.com - New Drug Approvals — Tue, 31 Jan 2012 23:01:15 +0100

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in... (Source: Drugs.com - New Drug Approvals)

Gemini Food Corporation and Tong Enterprises Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg

Food and Drug Administration — Tue, 31 Jan 2012 22:29:00 +0100

Gemini Food Corporation of City of Industry, CA and Tong Enterprises of Hayward, CA are recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens. People who have an allergy or severe sensitivity to eggs, run the risk of suffering serious or life-threatening reactions if they consume this product. (Source: Food and Drug Administration)

FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

Food and Drug Administration — Tue, 31 Jan 2012 22:29:00 +0100

How Sweet It Is Fudge and Candy Company, East Lansing, Michigan, Allergy Alert On Undeclared Milk Allergens In Products "Peanut Butter Buckeye" and â€œPeanut Butter Smoothieâ€� Date Code 01/23/2012 and Earlier

Food and Drug Administration — Tue, 31 Jan 2012 22:26:00 +0100

How Sweet It Is Fudge and Candy Company Inc. is recalling / correcting its 32 count packages of â€œPeanut Butter Buckeyeâ€� and â€œPeanut Butter Smoothieâ€� because they do contain undeclared milk allergens. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product. (Source: Food and Drug Administration)

Kalydeco - A Cystic Fibrosis Treatment

Health News from Medical News Today — Tue, 31 Jan 2012 21:00:00 +0100

Kalydeco has been approved by the Food And Drug Administration (FDA) to treat a vicious type of Cystic Fibrosis (CF). CF is a deadly recessive disease which targets the lungs, but can also harm the liver, pancreas, and intestine. It occurs from the unusual transport of chloride and sodium across the epithelium, causing mucus buildup in the lungs, and thick secretions. In turn, many respiratory problems occur in patients with CF. Diabetes is also common among patients with CF and it is most common among Caucasians... (Source: Health News from Medical News Today)

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Prevnar 13 Should Be Watched for Febrile Seizure RiskPrevnar 13 Should Be Watched for Febrile Seizure Risk

Medscape Today Headlines — Tue, 31 Jan 2012 20:14:41 +0100

The panel concurs with the Food and Drug Administration that the pneumococcal 13-valent conjugate vaccine should continue routine monitoring, including for febrile seizure risk. Medscape Medical News (Source: Medscape Today Headlines)

F.D.A. Approves Cystic Fibrosis Drug

NYT Health — Tue, 31 Jan 2012 19:13:02 +0100

The federal agency called it a “breakthrough therapy” because current therapies treat only the symptoms of the genetic disease. (Source: NYT Health)

FDA Approves KALYDECO (Ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis

Pharmaceutical Online News — Tue, 31 Jan 2012 18:33:00 +0100

Vertex Pharmaceuticals Incorporated announced recently that the U.S. Food and Drug Administration (FDA) has approved KALYDECOTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. (Source: Pharmaceutical Online News)

FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis

Drugs.com - New Drug Approvals — Tue, 31 Jan 2012 18:01:18 +0100

TUESDAY, January 31, 2012 -- The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic... (Source: Drugs.com - New Drug Approvals)

Obesity control drug by generic firm Lannett approved by FDA

bizjournals.com Health Care:Biotechnology headlines — Tue, 31 Jan 2012 16:10:50 +0100

Lannett Co. Inc. received its second approval for a generic drug product this week when the Food and Drug Administration cleared its application for phentermine hydrochloride capsules for use in the short-term management of obesity. Its product will join other generic phentermine products that generated sales of about $11 million last year, according to the pharmaceutical information services and publishing company Wolters Kluwer. Lannett (NYSE Amex:LCI) of Philadelphia said it expects to begin shipping the product shortly... (Source: bizjournals.com Health Care:Biotechnology headlines)

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FDA approves Kalydeco to treat rare form of cystic fibrosis

Food and Drug Administration — Tue, 31 Jan 2012 15:59:00 +0100

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. (Source: Food and Drug Administration)

Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g) Cans Batch Number 12832 Due to Possible Health Risk

Food and Drug Administration — Tue, 31 Jan 2012 15:39:00 +0100

Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States. (Source: Food and Drug Administration)

FDA takes action against New York cheese manufacturer

Food and Drug Administration — Tue, 31 Jan 2012 15:13:00 +0100

The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. (Source: Food and Drug Administration)

NPS Pharmaceuticals Announces FDA Acceptance Of New Drug Application For GATTEX (teduglutide) For The Treatment Of Adult Short Bowel Syndrome (SBS)

Pharmaceutical Online News — Tue, 31 Jan 2012 13:00:00 +0100

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, recently announced the U.S. Food and Drug Administration (FDA) has accepted and filed for review the company's New Drug Application (NDA) for GATTEX (teduglutide) for the treatment of adults with short bowel syndrome or SBS. (Source: Pharmaceutical Online News)

Vismodegib Granted FDA Approval for Treatment of Basal Cell Carcinoma

Cancer Network — Tue, 31 Jan 2012 12:00:00 +0100

The U.S. Food and Drug Administration (FDA) announced the approval of vismodegib (Erivedge), for the treatment of advanced basal cell carcinoma, the most common type of skin cancer, for patients who are not eligible for surgery or radiation, and for metastatic disease. (Source: Cancer Network)

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Nigeria: NAFDAC Deploys Regulatory Officers to Mega Drug Centres

AllAfrica News: Health and Medicine — Tue, 31 Jan 2012 10:26:07 +0100

Vanguard (Lagos)-dimensional approach towards fighting the knotty problem of drug counterfeiting, the National Agency for Food and Drug Administration and Control, NAFDAC, has deployed regulatory officers to man the new mega drug distribution centres built in some parts of the country. (Source: AllAfrica News: Health and Medicine)

FDA Approves Drug For Common Skin Cancer

Health News from Medical News Today — Tue, 31 Jan 2012 10:00:00 +0100

On Monday, the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer. The drug's generic name is vismodegib and was developed by the US part of Roche Holding AG. It will be sold in the US by Roche's South San Francisco-based Genentech under the brand name Erivedge. Basal cell carcinoma is a slow growing, painless cancer that starts in the epidermis, the top layer of skin. It usually starts in places that are regularly exposed to the sun or UV light... (Source: Health News from Medical News Today)

FDA hacked into private Gmail accounts of its own whistleblower scientist using covert spy technology

NaturalNews.com — Tue, 31 Jan 2012 06:00:00 +0100

The criminal tendencies of the U.S. Food and Drug Administration were on full display today when it was revealed the agency installed spy software and illegally hacked into the private Gmail accounts of at least half a dozen of its own top scientists. Those scientists... (Source: NaturalNews.com)

The Pharmacology and Therapeutic Use of Dabigatran Etexilate.

The Journal of Clinical Pharmacology — Tue, 31 Jan 2012 05:00:00 +0100

Authors: Spinler S Abstract Dabigatran etexilate is an oral prodrug of dabigatran, a direct thrombin inhibitor, that provides the first available oral anticoagulant alternative to warfarin for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). Although warfarin is effective, many patients with AF remain undertreated, primarily because of the management challenges associated with warfarin therapy. Dabigatran etexilate offers several potential advantages over warfarin, including fixed dosing, no requirement for blood coagulation monitoring, and reduced propensity for drug-drug interactions. In a large phase 3 trial in patients with nonvalvular AF, the US Food and Drug Administration (FDA)-approved dose of dabigatran etexilate (150...

FDA clears Pfizer Inlyta for kidney cancer

Drug Development Technology — Tue, 31 Jan 2012 00:00:00 +0100

The US Food and Drug Administration (FDA) has approved Pfizer's Inlyta (axitinib), a kinase inhibitor, intended for treating patients with advanced renal cell carcinoma (RCC) following failure of one prior systemic therapy. (Source: Drug Development Technology)

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FDA approves Amylin’s diabetes drug Bydureon

Pharmaceutical Technology — Tue, 31 Jan 2012 00:00:00 +0100

The US Food and Drug Administration (FDA) has approved Amylin’s once-weekly diabetes drug Bydureon at the third time of asking. (Source: Pharmaceutical Technology)

Pancrelipases, Xerese Cream Returned for Routine MonitoringPancrelipases, Xerese Cream Returned for Routine Monitoring

Medscape Today Headlines — Mon, 30 Jan 2012 23:50:30 +0100

Three pancrelipase formulations and an acyclovir/hydrocortisone cream have been returned for routine monitoring after US Food and Drug Administration reviews. Medscape Medical News (Source: Medscape Today Headlines)

Aveeno baby calming comfort lotion

Food and Drug Administration — Mon, 30 Jan 2012 23:22:00 +0100

Johnson & Johnson Consumer Companies, Inc. is voluntarily recalling from retailers one lot of AVEENO® BABY CALMING COMFORT® LOTION (full product details below) in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas. This is not a consumer level recall and no action is required by consumers. (Source: Food and Drug Administration)

Prescriptions Blog: F.D.A. Approves Drug for an Advanced Skin Cancer

NYT Health — Mon, 30 Jan 2012 20:44:47 +0100

The drug, Erivedge, made by Genentech, was approved for adults with basal cell carcinoma that has spread elsewhere in the body or those who are not candidates for surgery or radiation. (Source: NYT Health)

FDA doctors, scientists claim illegal surveillance

Reuters: Health — Mon, 30 Jan 2012 19:16:51 +0100

WASHINGTON (Reuters) - The U.S. Food and Drug Administration secretly monitored the private emails of staff doctors and scientists who alleged the agency was approving medical devices that posed a danger to patients, according to federal court documents. (Source: Reuters: Health)

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FDA Approves Erivedge for Basal Cell Carcinoma

Drugs.com - New Drug Approvals — Mon, 30 Jan 2012 17:01:36 +0100

SILVER SPRING, Md., Jan. 30, 2012 /PRNewswire-USNewswire/ -- Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is... (Source: Drugs.com - New Drug Approvals)

FDA approves Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma

Roche Media News — Mon, 30 Jan 2012 17:00:00 +0100

Roche today announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation. (Source: Roche Media News)

FDA approves new treatment for most common type of skin cancer

Food and Drug Administration — Mon, 30 Jan 2012 15:58:00 +0100

Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic). (Source: Food and Drug Administration)

Walgreen Co. Voluntarily Recalls Certain Lots of 13 Oz. Chocolate-Covered Raisins As Product May Contain Peanuts, Almonds, Soy Due to Packaging Error

Food and Drug Administration — Mon, 30 Jan 2012 15:54:00 +0100

Walgreen Co. is voluntarily recalling certain lots of 13-oz. Walgreens Chocolate-Covered Raisins because the packages may contain Walgreens Bridge Mix with peanut, almond and soy ingredients. The error occurred when Walgreens Bridge Mix was mistakenly packaged with the Walgreens Chocolate-Covered Raisin labeling. (Source: Food and Drug Administration)

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Pfizer Announces FDA Acceptance Of New Drug Application For Bosutinib For Patients With Previously Treated Ph+ Chronic Myeloid Leukemia

Drugs.com - New Drug Applications — Mon, 30 Jan 2012 15:01:54 +0100

NEW YORK--(BUSINESS WIRE)--Jan 27, 2012 - Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for standard review of bosutinib as a treatment option for adult patients with... (Source: Drugs.com - New Drug Applications)

Medtronic Announces FDA Approval Of DF4 High-Voltage Connector System For Implantable Cardioverter Defibrillator And Cardiac Resynchronization Therapy Devices

Medical Design Online News — Mon, 30 Jan 2012 14:00:00 +0100

Medtronic, Inc. today announced the U.S. Food and Drug Administration (FDA) approval and launch of the DF4 High-Voltage Connector System, a right ventricular lead and connector used with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to detect and accurately treat potentially life-threatening heart rhythms (Source: Medical Design Online News)

Baxter Announces FDA Approval Of Expanded Indication For TISSEEL [Fibrin Sealant] For General Hemostasis In Surgery

Medical Design Online News — Mon, 30 Jan 2012 14:00:00 +0100

Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical (Source: Medical Design Online News)

FDA Approves Inlyta (Axitinib) to Treat a Type of Advanced Kidney Cancer

MedlinePlus Health News — Mon, 30 Jan 2012 13:01:56 +0100

Source: Food and Drug Administration Related MedlinePlus Page: Kidney Cancer (Source: MedlinePlus Health News)

FDA Grants Approval to Axitinib for the Treatment of Advanced Renal Cell Carcinoma

Cancer Network — Mon, 30 Jan 2012 12:00:00 +0100

The U.S. Food and Drug Administration (FDA) has approved the angiogenesis blocker axitinib (Inlyta), a twice daily oral drug, as a second-line treatment for patients with advanced renal cell carcinoma. (Source: Cancer Network)

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FDA Approves Erivedge (vismodegib) Capsule, The First Medicine For Adults With Advanced Basal Cell Carcinoma

Pharmaceutical Online News — Mon, 30 Jan 2012 08:31:00 +0100

Roche recently announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation. (Source: Pharmaceutical Online News)

Bone Products in Surgery: A Blueprint for Standardization

AORN Journal — Mon, 30 Jan 2012 03:56:37 +0100

Abstract: Surgical facilities often stock many types of bone and bone products to meet the needs of multiple surgeons. In this era of cost containment, product standardization is necessary for the financial well-being of health care facilities. By familiarizing themselves with bone and bone product harvesting and processing and the US Food and Drug Administration requirements for approval of these products, perioperative nurses and managers can more easily standardize the bone and tissue products stocked and reduce costs. Steps toward standardization include establishing a multidisciplinary surgical product use committee to evaluate products used in the OR, limiting the number of tissue vendors for the facility to as few as possible, completing a product inventory to identify what is curr...

Amylin and Alkermes diabetes drug wins FDA approval

Drug Development Technology — Mon, 30 Jan 2012 00:00:00 +0100

Amylin Pharmaceuticals and Alkermes have announced that the US Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) for the treatment of type 2 diabetes. (Source: Drug Development Technology)

FDA approves Inlyta for advanced kidney cancer

Kidney Cancer Association — Sun, 29 Jan 2012 20:36:01 +0100

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.02/29/2012 (Source: Kidney Cancer Association)

Evaluation of Automatic Class III Designation (De Novo) Decision : K093295 added

Food and Drug Adminstration (FDA): CDRHNew — Sun, 29 Jan 2012 05:00:00 +0100

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. (Source: Food and Drug Adminstration (FDA): CDRHNew)

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What does Section 8.4 of prescription drug label mean to pediatricians? [FDA UPDATE]

AAP News — Sun, 29 Jan 2012 05:00:00 +0100

(Source: AAP News)

Amylin's Once-Weekly Diabetes Injection Finally Wins FDA Approval

Health News from Medical News Today — Sat, 28 Jan 2012 23:00:00 +0100

On Friday, the US Food and Drug Administration finally approved Amylin Pharmaceutical's diabetes drug Bydureon, which provides glycemic control for diabetes type 2 in a once-weekly injection. The approval follows two earlier rejections in 2010, when the FDA asked the company to go back and carry out a new trial of the drug's effect on heart rhythm. The company describes Bydureon (exenatide extended-release for injectable suspension) as the first of its kind. It is a once-a- week version of Byetta, the company's 7-year-old diabetes drug that has to be injected twice a day... (Source: Health News from Medical News Today)

Bydureon, a Diabetes Drug from Amylin, Wins F.D.A. Approval

NYT Health — Sat, 28 Jan 2012 06:10:08 +0100

The Food and Drug Administration twice declined to approve Bydureon in 2010, with its most serious concern being that the drug might contribute to heart rhythm abnormalities. (Source: NYT Health)

FDA may legalize pot medicine, but only for Big Pharma

NaturalNews.com — Sat, 28 Jan 2012 06:00:00 +0100

(NaturalNews)The pressure is on for researchers and pharmaceutical companies to develop drug-based, non-synthetic versions of marijuana for medical use, as the US Food and Drug Administration (FDA) is poised to approve such varieties in the near future. But this potential approval... (Source: NaturalNews.com)

Bydureon, a Diabetes Drug from Amylin, Wins F.D.A. Approval

NYT — Sat, 28 Jan 2012 05:33:03 +0100

The Food and Drug Administration twice declined to approve Bydureon in 2010, with its most serious concern being that the drug might contribute to heart rhythm abnormalities. (Source: NYT)

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Pinnacle Foods Group LLC Issues Allergy Alert On Undeclared Soy Protein In Aunt Jemima Frozen Pancakes

Food and Drug Administration — Sat, 28 Jan 2012 02:37:00 +0100

Out of regard and concern for our consumers, Pinnacle Foods Group LLC is recalling certain Aunt Jemima Frozen Pancakes. The product may contain soy protein, an undeclared allergen. (Source: Food and Drug Administration)

Maker recalls 2,200 tubes of Aveeno baby lotion

CNN.com - Health — Sat, 28 Jan 2012 01:57:08 +0100

Johnson & Johnson announced Friday it is voluntarily recalling a single lot of Aveeno Baby Calming Comfort Lotion after a test by the Food and Drug Administration found it contained more of a form of bacteria than specifications allow. (Source: CNN.com - Health)

FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes

Drugs.com - New Drug Approvals — Sat, 28 Jan 2012 01:01:54 +0100

SAN DIEGO and DUBLIN, Jan. 27, 2012 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. and Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has approved Bydureon (exenatide extended-release for injectable suspension) – the... (Source: Drugs.com - New Drug Approvals)

FDA Approves Inlyta for Advanced Renal Cell Carcinoma

Drugs.com - New Drug Approvals — Fri, 27 Jan 2012 22:01:37 +0100

FRIDAY, January 27, 2012 -- The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. Renal cell... (Source: Drugs.com - New Drug Approvals)

Inlyta (axitinib) Approved For Advanced Kidney Cancer, USA

Health News from Medical News Today — Fri, 27 Jan 2012 22:00:00 +0100

The US FDA has approved Inlyta (axitinib) for the treatment of advanced renal cell carcinoma, a type of kidney cancer, in patients with whom other drugs have not been effective, the FDA (Food and Drug Administration) announced today. Inlyta is made and marketed by pharmaceutical giant Pfizer Inc. Renal cell carcinoma - also known as renal cell cancer or hypernephroma, is a type of kidney cancer that starts in the lining of the tiny renal tubes (proximal convoluted tubule). These tubes filter the blood and produce urine. This type represents 80% of all kidney cancers... (Source: Health News from Medical News Today)

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Cephalon, Inc. issues a voluntary nationwide recall of TreandaÂ® (bendamustine HCL) for Injection 25mg/Vial Due to Particulate Matter

Food and Drug Administration — Fri, 27 Jan 2012 21:00:00 +0100

Cephalon, Inc. is voluntarily recalling TreandaÂ® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012.Â This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments (Source: Food and Drug Administration)

FDA Finds Fungicide In OJ From Brazil, Canada

WDSU.com - Health — Fri, 27 Jan 2012 20:59:35 +0100

The U.S. Food and Drug Administration said on Friday it had detained shipments of orange juice and concentrate from Brazil and Canada after finding traces of the unapproved fungicide carbendazim. (Source: WDSU.com - Health)

FDA finds fungicide in Brazil, Canada orange juice

CNN.com - Health — Fri, 27 Jan 2012 20:44:02 +0100

FDA approves Inlyta to treat patients with a type of advanced kidney cancer

Food and Drug Administration — Fri, 27 Jan 2012 17:09:00 +0100

Keppra® Approved By FDA For Childhood Seizures

Health News from Medical News Today — Fri, 27 Jan 2012 17:00:00 +0100

In the U.S., Keppra® has been approved as adjunctive therapy for partial onset seizures in adults and children aged four years and older with epilepsy. However the UCB recently announced that the U.S. Food and Drug Administration (FDA) has now approved to lower the age restriction to include infants from the age of one month and older with epilepsy. Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB â�¨declared: â�¨"As a leader in epilepsy UCB has a responsibility to develop effective medicines that address unmet medical needs... (Source: Health News from Medical News Today)

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Enforcement Report for January 25, 2012

Food and Drug Administration--Enforcement Report — Fri, 27 Jan 2012 14:59:00 +0100

(Source: Food and Drug Administration--Enforcement Report)

FDA Approves BYDUREON™ - The First And Only Once-Weekly Treatment For Type 2 Diabetes

Pharmaceutical Online News — Fri, 27 Jan 2012 08:58:00 +0100

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) - the first once-weekly treatment for type 2 diabetes. (Source: Pharmaceutical Online News)

Stemedica Completes Pre-IND Meeting with the FDA for Ischemic Tolerant...

PRWeb: Medical Pharmaceuticals — Fri, 27 Jan 2012 06:33:34 +0100

Stemedica announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigational New Drug) application to evaluate the safety and...(PRWeb January 24, 2012)Read the full story at http://www.prweb.com/releases/2012-stemedica-FDA/PRE-IND-ITNSC-STEM-CELL/prweb9133781.htm (Source: PRWeb: Medical Pharmaceuticals)

Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Hydromorphone

HSMN NewsFeed — Thu, 26 Jan 2012 16:57:54 +0100

NORTHVALE, N.J., Jan. 26, 2012 --(HSMN NewsFeed) -- Elite Pharmaceuticals, Inc. ("Elite") (OTCBB:ELTP.OB ) announced today that on January 23, 2012, the U.S. Food and Drug Administration approved the Company's supplemental application for the man... Biopharmaceuticals, FDAElite Pharmaceuticals, Hydromorphone (Source: HSMN NewsFeed)

M.E. Thompson, Inc. Recalls Anytime Deli Brand Turkey & Ham Footlong Sandwich Because Of Possible Health Risk

Food and Drug Administration — Thu, 26 Jan 2012 15:10:00 +0100

M.E. Thompson, Inc. of Jacksonville, FL is recalling its Anytime Deli Turkey & Ham Sub Sandwich, UPC 0543200194, with an expiration date of January 19th and January 22nd because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. (Source: Food and Drug Administration)

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Department of Justice files Consent Decree of Permanent injunction against Ranbaxy

Food and Drug Administration — Wed, 25 Jan 2012 21:59:00 +0100

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities (Source: Food and Drug Administration)

FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing

Drugs.com - New Drug Approvals — Wed, 25 Jan 2012 19:01:52 +0100

PARSIPPANY, N.J., January 25, 2012, 2012 /PRNewswire/ -- Leo Pharma announced today that the U.S. Food and Drug Administration (FDA) approved Picato (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). AK is... (Source: Drugs.com - New Drug Approvals)

UCB Announces FDA Approval for Keppra in Infants and Children from One Month of Age with Partial Onset Seizures

Drugs.com - New Drug Approvals — Wed, 25 Jan 2012 18:01:31 +0100

ATLANTA--(BUSINESS WIRE)--Jan 25, 2012 - UCB announced today that the U.S. Food and Drug Administration (FDA) has approved Keppra (levetiracetam) tablets and oral solution as adjunctive therapy in the treatment of partial onset seizures... (Source: Drugs.com - New Drug Approvals)

New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease

Drugs.com - New Drug Approvals — Wed, 25 Jan 2012 16:01:37 +0100

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 25, 2012 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for... (Source: Drugs.com - New Drug Approvals)

Repeat business? FDA approves new cancer drug to treat toxicity caused by another cancer drug

NaturalNews.com — Wed, 25 Jan 2012 06:00:00 +0100

The US Food and Drug Administration (FDA) has approved a new cancer drug that allegedly treats the deadly side effects caused by another popular cancer drug. The new drug, Voraxaze (glucarpidase), is said to expel methotrexate, a commonly prescribed and highly toxic... (Source: NaturalNews.com)

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Ciclesonide - A Novel Corticosteroid for the Management of Asthma.

Current Clinical Pharmacology — Wed, 25 Jan 2012 05:00:00 +0100

Authors: Chopra D, Bhandari B, Vardhan N Abstract Ciclesonide (CIC) is a novel inhaled corticosteroid (ICS) approved by US Food and Drug Administration for the treatment of persistent asthma, available as a pressurized metered-dose inhaler in two strengths, 80 mcg/activation and 160 mcg/activation. Ciclesonide is a corticosteroid with unique pharmacological profile including a high degree of serum protein binding, a low oral bioavailability and rapid systemic elimination. Ciclesonide is a prodrug metabolized by esterases to desisobutyryl ciclesonide (des-CIC), an active metabolite with a 100-fold greater affinity for the glucocorticoid receptor. It has shown to improve pulmonary functions, reduce the need for oral corticosteroids (OCSs) and cause lesser suppression of the hypothala...

Medtronic Completes Enrollment of Extreme Risk Patient Group in CoreValve(R) U.S. Pivotal Trial

News from Angioplasty.Org — Wed, 25 Jan 2012 03:00:00 +0100

Medtronic, Inc. (NYSE: MDT) today announced it has completed patient enrollment in the extreme risk study in its CoreValve U.S. Pivotal Trial. The company also received approval from the U.S. Food and Drug Administration (FDA) for an extended investigation (under the FDA's Continued Access Policy) to continue enrolling extreme risk patients under a Continued Access Study protocol. In the Trial's second study evaluating high risk patients for aortic valve surgery, enrollment completion is anticipated later this year. (Source: News from Angioplasty.Org)

FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis

Drugs.com - New Drug Approvals — Wed, 25 Jan 2012 00:01:23 +0100

FRIDAY, January 20, 2012 - The U.S. Food and Drug Administration today approved Zetonna (ciclesonide) nasal aerosol to treat the symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and... (Source: Drugs.com - New Drug Approvals)

Maine company holds cold smoked salmon product after FDA order

Food and Drug Administration — Tue, 24 Jan 2012 23:04:00 +0100

A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment (Source: Food and Drug Administration)

MedWorm: Food and Drug Administration (FDA)

A systematic review of validated methods for identifying suicide or suicidal ideation using administrative or claims data. - Walkup JT, Townsend L, Crystal S, Olfson M.

Proton Pump Inhibitors Raise Persistent Diarrhea Risk, Warns FDA

Deep brain stimulation enhances spatial memory

Consumers want tougher probe of engineered salmon

FDA Will Speed Up Review of Roche Cancer Drug

Merck provides suvorexant insomnia update

FDA grants Roche's pertuzumab Priority Review for previously untreated HER2-positive metastatic breast cancer

Stimulant treatment for ADHD not associated with increased risk of cardiac events in youth

Horizon scanning: FDA approves VyvanseT (lisdexamfetamine dimesylate) for maintenance of ADHD in adults

Horizon scanning: FDA approves SkliceT (ivermectin) Lotion for the treatment of head lice

Horizon scanning: FDA Grants priority review of crofelemer for diarrhoea in patients with HIV/AIDS on anti-retroviral therapy

Horizon scanning: FDA Grants priority review of pertuzumab for untreated HER2-Positive metastatic breast cancer

Horizon scanning: AmiKetT for peripheral neuropathic pain filed for FDA fast track designation

IV acetaminophen potential source of pediatric dosing errors

Consumer groups want tougher probe of engineered salmon

The emergence of diagnostic imaging technologies in breast cancer: discovery, regulatory approval, reimbursement, and adoption in clinical guidelines.

EpiCept files fast track status for AmiKet

Sanofi head-lice lotion wins FDA approval

Sanofi Announces FDA Approval of Sklice Lotion for the Treatment of Head Lice

The comparative research on constituents of Radix Aconiti and its processing by HPLC quadrupole TOF-MS.

Ziopharm oral Palifosfamide gets FDA IND approval

FDA staff unsure about new use for Amgen's Xgeva

North American Rescue, LLC Announces A Follow-Up to the Recall of Crickit Convenience Kits Because of Possible Health Risk Related to Nationwide Recall of Triad Povidone Iodine Prep Pads

FDA staff unsure about new use for Amgen's Xgeva

While government discredits raw milk, it keeps names of salmonella outbreak restaurants secret to protect corporate profits

E. Coli O157:H7 Population Reduction from Alfalfa Seeds with Malic Acid and Thiamine Dilauryl Sulfate and Quality Evaluation of the Resulting Sprouts

US FDA approves ivacaftor for treatment of rare form of cystic fibrosis

Immunology in clinic review series; focus on autoinflammatory diseases: update on monogenic autoinflammatory diseases: the role of interleukin (IL)-1 and an emerging role for cytokines beyond IL-1.

Healthy People Co. Issues a Voluntary Recall of Specific Lots of the Dietary Supplements Found to Contain Undeclared Drug Ingredients

Nest Collective Voluntarily Recalls Select Revolution Foods Jammy Sammy - Strawberry Jam & Peanut Butter Snack Size Sandwich Bars Due to a Labeling Error (Undeclared Peanut on Inner Wrapper)

California Firm Recalls Prepared Sandwiches that Contain Hard-Cooked Eggs

Greencore, USA â€“ Cincinnati, Recalls Egg Salad Sandwiches with Brand Name Quick CafÃ© and Take Away CafÃ© because of Possible Health Risk

Talon leukemia drug gets date with FDA advisory panel

Friday Report from GU ASCO; Biomarkers

Enforcement Report for February 1, 2012

New device removes stroke-causing blood clots better than standard treatment

Tainted juice saga reveals shocking truth about how much food we import

Allisonâ€™s Gourmet Kitchens Recalls Prepared Salads that Contain Hard Cooked Eggs Due to Potential Health Risk.

Vismodegib approved by US FDA for treatment of basal cell carcinoma

Merck receives FDA approval for Janumet

Prescriptions Blog: Drug Makers Dial Down TV Advertising

Bedford Laboratories Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution, USP, LOT 1877093

Wegmans Recalls Various Prepared Foods That Contain Hard-Cooked Eggs Produced by Michael Foods

S&M USA Enterprise Issues an Alert on Undeclared Sulfites in Zhang Zhou Brand Tremella

FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience

Updated News Release With Corrected Lot Numbers: Advanced Animal Nutrition Recalls Dog Power Dry Dog Food

W & C International Import Inc. Issues An Alert On Un-Eviscerated "Rely" Dried Yellow Croaker

W & C International Import Inc. Issues an Alert on Un-eviscerated â€œRelyâ€� Sardine Anchovies

Medical Device Industry And FDA Reach Provisional Fees Agreement

New online databases help patients find adverse event

Immunology in clinic review series; focus on autoinflammatory diseases: update on monogenic autoinflammatory diseases: the role of interleukin (IL)‐1 and an emerging role for cytokines beyond IL‐1

Mylan Receives Tentative FDA Approval For Generic Version Of Lipitor®

Bayer Initiates Expanded Access Program For Investigational Compound Radium-223 Chloride

Leading Medical Groups Collaborate To Ensure Consistent, Responsible Uptake Of Transcatheter Aortic Valve Replacement

In Patients With Drug-Resistant Prostate Cancer, New Drug Extends Survival

FDA clears Cynosure's cellulite-treating laser

Novartis Glivec wins extended FDA approval for three-year treatment

No need to loosen conflict rules, U.S. FDA head says

Michael Foods Recalls Hard-Cooked Eggs Packed In Brine Sold In 10- And 25-Pound Pails Because Of Possible Health Risk

Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin

Toshiba gets FDA nod for Aquilion Prime CT

Erivedge - Treatment For Most Common Form Of Skin Cancer

Scientists suing the FDA after covert surveillance

FDA and industry reach agreement in principle on medical device user fees

FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes

Amylin's long-delayed diabetes drug gets US nod (Associated Press, 28 January 2012)

F.D.A. Approves Cystic Fibrosis Drug

FDA approves new skin cancer drug first tested in Arizona by Scottsdale Healthcare and TGen

Ruxolitinib

FDA OKs ingenol mebutate for AK treatment

FDA approves vismodegib for basal cell cancers

Pediatric Analgesic Clinical Trial Designs, Measures, and Extrapolation: Report of an FDA Scientific Workshop

Top 10 articles: what do they tell us?

President Global Corporation Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg

Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets

Funding bill may address drug shortages-aides

Boehringer, Eli Lilly diabetes drug wins FDA nod

Roche’s skin cancer drug Erivedge given FDA nod

FDA Approves Gleevec for Expanded Use in Patients with Rare Gastrointestinal Cancer