Alembic Pharma gets USFDA’s final nod for Paroxetine Extended-Release Tablets
The approved sANDA is therapeutically equivalent to the reference listed drug product, Paxil CR Tablets, 12.5 mg, of Apotex Inc
Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg.
The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, of Apotex Inc. Paroxetine extended-release tablets are indicated for the treatment of Major depressive disorder (MDD), Panic disorder (PD), Social anxiety disorder (SAD), and Premenstrual dysphoric disorder (PMDD). Alembic has a cumulative total of 235 ANDA approvals (216 final approvals and 19 tentative approvals) from USFDA.
Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
