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Supernus Resubmits NDA for SPN-812 for ADHD in Pediatric Patients americanpharmaceuticalreview
February 10, 2021
Supernus Pharmaceuticals has resubmitted its New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients.
Glenmark Pharma gets USFDA approval for Amphetamine Sulfate Tablets expresspharma
January 28, 2021
The tablets are used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, a sleeping disorder.
Supernus Announces Positive Results from SPN-812 Study for ADHD americanpharmaceuticalreview
December 31, 2020
Supernus Pharmaceuticals has announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).
Tris Pharma, Neuraxpharm Announce Partnership americanpharmaceuticalreview
December 28, 2020
Tris Pharma and Neuraxpharm Group have entered into an agreement whereby Neuraxpharm received exclusive rights to commercialize Tris' FDA-approved Quillivant XR and Quillichew ER in Europe.
Supernus Provides Regulatory Updates for SPN-812 and SPN-830 americanpharmaceuticalreview
November 20, 2020
Supernus Pharmaceuticals announced regulatory updates for SPN-812 (viloxazine hydrochloride) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age, and SPN-830 (apomorphine infusion pump) for ...
Granules gets USFDA nod for ADHD drug dexmethylphenidate HCl extended-release capsules expresspharma
September 23, 2020
The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia.
Dr Reddy’s Labs launch methylphenidate hydrochloride extended-release tablets USP in US expresspharma
September 04, 2020
It is indicated for treatment of ADHD in children six years of age and older, adolescents, and adults up to the age of 65.
KemPharm Receives of Two Additional U.S. Patents americanpharmaceuticalreview
August 04, 2020
KemPharm announced the United States Patent and Trademark Office (USPTO) has recently issued two new patents to KemPharm governing methods of use and composition of matter for methylphenidate-based prodrugs.
American BriVision First Patient Enrolled for Adult ADHD Trial americanpharmaceuticalreview
March 06, 2020
American BriVision announced the first patient enrollment of ABV-1505 Phase II Part I clinical trial, under the U.S. Food and Drug Administration (FDA) clinical protocol code BLI-1008-001 ...
KemPharm Submits KP415 NDA to FDA for ADHD americanpharmaceuticalreview
March 04, 2020
KemPharm has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its investigational product candidate, KP415, to the U.S. Food and Drug Administration (FDA).

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