Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.

The approved product is therapeutically equivalent to Paxil CR Extended-Release Tablets (25 mg and 37.5 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).

Headquartered in India, Alembic Pharmaceuticals is a publicly listed company engaged in the manufacture and global marketing of generic pharmaceutical products. With this approval, the company’s cumulative tally of ANDA approvals from the USFDA stands at 226, comprising 205 final approvals and 21 tentative approvals.