Alembic Pharmaceuticals Limited (Alembic) announced that it 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). Refer label for a detailed indication.
Alembic has a cumulative total of 235 ANDA approvals (216 final approvals and 19 tentative approvals) from USFDA.
