Alembic Pharmaceuticals gets USFDA approval for Paroxetine

Alembic Pharmaceuticals Limited announced on September 25, 2025, 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. This approval allows Alembic to market a therapeutically equivalent version of Apotex Inc.'s Paxil CR Extended-Release Tablets.

The approved tablets are indicated for treating Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD). This latest approval brings Alembic's cumulative total of ANDA approvals to 226, comprising 205 final approvals and 21 tentative approvals from the USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development company that manufactures and markets generic pharmaceutical products globally.