Enforcement Report - Week of June 7, 2023
Humanwell's Generic Amantadine Hydrochloride Receives Approval in the U.S.
The United States Food and Drug Administration (FDA) has granted tentative approval to market Zydus Pharma’s Amantadine extended-release capsules USP 68.5 mg and 137 mg.
Zydus's Generic Amantadine Receives Approval in the U.S.
Strides Pharma arm gets USFDA nod to market Amantadine Hydrochloride Softgel Capsules in America
Strides Pharma's Generic Amantadine Hydrochloride Receives Approval in the U.S.
Invatech's Generic Amantadine Hydrochloride Receives Approval In the US
Invatech's Generic Amantadine Hydrochloride Receives Approval In the US
Alembic Pharms Generic Amantadine Hydrochloride Receives Approval in US
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced its presentation of a new post-hoc pivotal trial data analysis at the American Academy of Neurology (AAN) Science Highlights Platform showing GOCOVRI decreasing dyskinesia and OFF time for people with Parkinson’s Disease (PD) using GOCOVRI® (amantadine) extended release capsules. GOCOVRI is indicated for the treatment of dyskinesia in people with Parkinson's disease receiving levodopa-based therapy. The abstract and poster presentation are available on the 2020 AAN Science Highlights Platform.