By: IPP Bureau
Last updated : September 26, 2025 10:01 am
Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder
Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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.
Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, 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 226 ANDA approvals (205 final approvals and 21 tentative approvals) from USFDA.