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Management: Food and Drug Administration (FDA)

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Total 75 results found since Jan 2013.

FDA Approves First Generic Strattera for the Treatment of ADHD
May 30, 2017 -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals...
Source: Drugs.com - Pharma News - May 30, 2017 Category: Pharmaceuticals Source Type: news

FDA gives Lannett more time to make its case for ADHD drug
The Food and Drug Administration has decided to give Lannett Co. Inc. more time to show why its generic ADHD drug should be allowed to remain in the market. Back in October, the FDA informed the Northeast Philadelphia generic drug manufacturer that the agency was preparing to withdraw its approval of the company’s Methylphenidate Hydrochloride extended-release tablets, prescribed to treat attention deficit hyperactivity disorder, based in part on re ports by patients that the therapeutics benefits…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - February 22, 2017 Category: Pharmaceuticals Authors: John George Source Type: news

U.S. FDA Acknowledges Receipt of Shire ’s New Drug Application for SHP465 for ADHD
Lexington, Mass., USA – January 19, 2017 –– Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a...
Source: Drugs.com - New Drug Applications - January 19, 2017 Category: Drugs & Pharmacology Source Type: news

Mylan launches two new generics this week
Mylan announced this week it would launch two new generics in the U.S. market after receiving final approval, one for the treatment of ADHD and the other a birth control drug. Mylan's subsidiary, Jai Pharma Limited, received final approval from the U.S. Food and Drug Administration for its ethynodiol diacetate and ethinyl estradiol tablets, therapeutic equivalents of the brand name birth control drug Zovia. Mylan itself received final approval from the FDA for methylphe nidate hydrochloride extended-release…
Source: bizjournals.com Health Care:Biotechnology headlines - December 30, 2016 Category: Biotechnology Authors: Lydia Nuzum Source Type: news

Neos Therapeutics resubmits ADHD drug marketing application
(Reuters) - Drug developer Neos Therapeutics Inc said on Tuesday it resubmitted the marketing application for its attention deficit/hyperactivity disorder (ADHD) drug to the U.S. Food and Drug Administration.
Source: Reuters: Health - December 20, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Alcobra Plunges After FDA Places Hold on ADHD Drug Alcobra Plunges After FDA Places Hold on ADHD Drug
Alcobra Ltd ' s market value more than halved on Thursday, a day after the company said the U.S. Food and Drug Administration had placed a hold on its lead experimental drug.Reuters Health Information
Source: Medscape Medical News Headlines - September 30, 2016 Category: Consumer Health News Tags: Pharmacist News Source Type: news

Alcobra plunges after FDA places hold on ADHD drug
(Reuters) - Alcobra Ltd's market value more than halved on Thursday, a day after the company said the U.S. Food and Drug Administration had placed a hold on its lead experimental drug.
Source: Reuters: Health - September 29, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Important Health Stories You May Have Missed
There's never a shortage of health-related headlines. I don't envy the editors of The Week magazine, who have to sift through countless inane weight-loss stories as well as seemingly important new research to determine just the right fit for the magazine's "Health Scare of the Week" column. Like those editors, the public has the arduous responsibility of judiciously deciding what news stories to toss aside and what stories to accept as important. Last week's story said red wine will protect your heart, this week it's toxic, and next week your choice of wine or beer make determine whether you are alive or dead by age 55......
Source: Healthy Living - The Huffington Post - September 27, 2016 Category: Consumer Health News Source Type: news

Ritalin Could Trigger Heart Problems In Children
Ritalin and similar forms of ADHD medication may trigger abnormal heart rhythms and increase heart attack risk in some children soon after they start taking the drug, according to a new study.  This connection was especially true for children who were born with heart disease. According to the study, published in the British medical journal BMJ, kids had an increased risk of heart attack between eight and 56 days after starting methylphenidate, a stimulant most commonly sold as Ritalin, although this heightened risk didn’t reach statistical significance. The researchers could find no evidence of a heightened...
Source: Science - The Huffington Post - June 8, 2016 Category: Science Source Type: news

FDA approves Neos Therapeutics' long-acting ADHD drug
(Reuters) - Neos Therapeutics Inc's drug to treat a common type of childhood behavioral disorder was approved by the U.S. Food and Drug Administration, making it the first of its kind to win U.S. approval.
Source: Reuters: Health - January 28, 2016 Category: Consumer Health News Tags: healthNews Source Type: news

Why Are So Many College and High School Kids Abusing Adderall
During the past 15 years, there has been a remarkable transformation in the drug trade. It used to be dominated by the illegal drug cartels. Now it it is dominated by the legal drug companies. The most dangerous legal drugs are the prescription opioids, now responsible for twice as many deaths as street drugs and also for a secondary epidemic of heroin addiction. The next most dangerous legal drugs are Xanax and other short acting benzodiazepines that potentiate overdoses, cause severe addiction, raise the risk of falls, and worsen cognitive problems. ADHD meds are the most dangerous legal drugs among young people in co...
Source: Science - The Huffington Post - November 9, 2015 Category: Science Source Type: news

FDA finds deficiencies in Neos' marketing application for ADHD drug
(Reuters) - Neos Therapeutics Inc said the U.S. Food and Drug Administration identified deficiencies that preclude discussion of labeling and marketing requirements for the company's treatment of a common type of behavioral disorder.
Source: Reuters: Health - October 19, 2015 Category: Consumer Health News Tags: healthNews Source Type: news

More American Children Diagnosed with ADHD
U.S. Food and Drug Administration offers tips on coping with attention disorder Source: HealthDay Related MedlinePlus Page: Attention Deficit Hyperactivity Disorder
Source: MedlinePlus Health News - August 14, 2015 Category: Consumer Health News Source Type: news

Shire touts plan to extend dominance in ADHD market through 2029
This morning, drug giant Shire said a long-acting drug in development for attention-deficit hyperactivity disorder that could help the company fend off competition from generics until 2029 could launch in a little over two years, based on feedback from the Food and Drug Administration. Shire (Nasdaq: SHPG), whose U.S. headquarters are in Lexington, has been developing the ADHD drug known as SHP465 for years using the same active ingredient as its former best-selling drug, Adderall XR. It first filed…
Source: bizjournals.com Health Care:Physician Practices headlines - April 7, 2015 Category: American Health Authors: Don Seiffert Source Type: news