Filtered By:
Management: Food and Drug Administration (FDA)

This page shows you your search results in order of date. This is page number 3.

Order by Relevance | Date

Total 75 results found since Jan 2013.

The New Depression Treatment Esketamine Helped Me Get My Life Back. But I Don ’t Know If I Can Keep Taking It
On Tuesday, the Food and Drug Administration (FDA) approved the U.S.’ first new major depression treatment in years: a fast-acting esketamine nasal spray related to the club drug ketamine, which is itself a promising treatment for depression. The esketamine spray, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and sold under the brand name Spravato, is intended for adults with treatment-resistant depression. When taken in conjunction with oral antidepressants under medical supervision, Spravato has been shown to ease depression systems in as little as hours, though the psychedelic-derived drug ...
Source: TIME: Health - March 7, 2019 Category: Consumer Health News Authors: Amelia D. Tags: Uncategorized Drugs healthytime onetime Source Type: news

The New Depression Treatment Esketamine Helped Me Get My Life Back. But I Don ’t Know If I Can Take It Forever
On Tuesday, the Food and Drug Administration (FDA) approved the U.S.’ first new major depression treatment in years: a fast-acting esketamine nasal spray related to the club drug ketamine, which is itself a promising treatment for depression. The esketamine spray, manufactured by Johnson & Johnson’s Janssen Pharmaceuticals and sold under the brand name Spravato, is intended for adults with treatment-resistant depression. When taken in conjunction with oral antidepressants under medical supervision, Spravato has been shown to ease depression systems in as little as hours, though the psychedelic-derived drug ...
Source: TIME: Health - March 7, 2019 Category: Consumer Health News Authors: Amelia D. Tags: Uncategorized Drugs healthytime onetime Source Type: news

FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD
STAMFORD, Conn.--(BUSINESS WIRE) March 01, 2019 --Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules...
Source: Drugs.com - New Drug Approvals - March 1, 2019 Category: Drugs & Pharmacology Source Type: news

North Texas biotech settles litigation over ADHD drug
Grand Prairie-based Neos Therapeutics Inc. entered into a confidential settlement and licensing agreement with Teva Pharmaceuticals USA Inc. to resolve all ongoing litigation involving Neos' patents for its Cotempla product. The two companies got involved in litigation after Teva Pharmaceuticals USA of North Wales, Pennsylvania, filed an application with the Food and Drug Administration to market a generic version of the medicine used to treat attention deficit hyperactivity disorder. Under the…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 27, 2018 Category: Pharmaceuticals Authors: John George Source Type: news

Neos, Teva settle litigation over ADHD drug
Neos Therapeutics Inc. entered into a confidential settlement and licensing agreement Wednesday with Teva Pharmaceuticals USA Inc. to resolve all ongoing litigation involving Neos' patents for its Cotempla product. The two companies got involved in litigation after Teva Pharmaceuticals USA of North Wales, Pa., filed an application with the Food and Drug Administration to market a generic version of the medicine used to treat attention deficit hyperactivity disorder. Under the settlement and license…
Source: bizjournals.com Health Care:Biotechnology headlines - December 26, 2018 Category: Biotechnology Authors: John George Source Type: news

FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) August 31, 2018 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a...
Source: Drugs.com - New Drug Applications - August 31, 2018 Category: Drugs & Pharmacology Source Type: news

Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) November 10, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel...
Source: Drugs.com - New Drug Applications - November 10, 2017 Category: Drugs & Pharmacology Source Type: news

Sunovion submits NDA for dasotraline to US FDA to treat ADHD patients
Sunovion Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for dasotraline to treat patients with attention deficit hyperactivity disorder (ADHD).
Source: Pharmaceutical Technology - September 3, 2017 Category: Pharmaceuticals Source Type: news

Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD
MARLBOROUGH, Mass.--(BUSINESS WIRE) August 31, 2017 --Sunovion Pharmaceuticals Inc. (Sunovion) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dasotraline, a novel...
Source: Drugs.com - New Drug Applications - August 31, 2017 Category: Drugs & Pharmacology Source Type: news

Greater Cincinnati company teams with Kansas startup to steer approval of ADHD drugs
A Greater Cincinnati company has partnered with a Kansas pharmaceutical startup to help advance its development of two new ADHD treatments. Cingulate Therapeutics LLC, based in Kansas City, Kan., entered a service agreement with Blue Ash-based Camargo Pharmaceutical Services, which provides comprehensive drug development services, to help prepare the company’s submissions to the Food and Drug Administration. “We’re excited to h ave them as our partner on this,” Cingulate CEO Shane Schaffer…
Source: bizjournals.com Health Care:Biotechnology headlines - August 14, 2017 Category: Biotechnology Authors: Elise Reuter Source Type: news

Shire receives FDA approval for Mydayis to treat attention deficit hyperactivity disorder
Biotechnology company Shire has received the US Food and Drug Administration (FDA) approval for Mydayis (mixed salts of a single-entity amphetamine product) for the treatment of attention deficit hyperactivity disorder (ADHD).
Source: Pharmaceutical Technology - June 21, 2017 Category: Pharmaceuticals Source Type: news

FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD
Lexington, Mass., USA – June 20, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment...
Source: Drugs.com - New Drug Approvals - June 21, 2017 Category: Drugs & Pharmacology Source Type: news

Shire's long-acting ADHD drug wins U.S. approval
(Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday approved Shire Plc's long-acting therapy for attention deficit hyperactivity disorder (ADHD), adding another treatment to its stock of drugs for the cognitive condition that affects millions of children.
Source: Reuters: Health - June 20, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

FDA approves first generic Strattera for the treatment of ADHD
The U.S. Food and Drug Administration has approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited gained approval to market atomoxetine in multiple strengths.
Source: World Pharma News - May 31, 2017 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news