Alembic Pharmaceuticals Receives USFDA Final Approval for Paroxetine Extended-Release Tablets

Alembic Pharmaceuticals Ltd has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Extended-Release Tablets, 25 mg and 37.5 mg, of Apotex Inc. The 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 226 ANDA approvals (205 final approvals and 21 tentative approvals) from USFDA.