Alembic Pharmaceuticals Ltd. announced on Thursday that it has secured final approval from the US health regulator for its generic version of Paroxetine extended-release (ER) tablets, used in the treatment of depression and anxiety.
The US Food & Drug Administration (USFDA) has granted final approval for the company’s abbreviated new drug application (ANDA) for Paroxetine ER tablets in 25 mg and 37.5 mg strengths, Alembic Pharmaceuticals stated in a regulatory filing.
The approved ANDA is considered therapeutically equivalent to the reference listed drug, Paxil CR extended-release tablets, 25 mg and 37.5 mg, marketed by Apotex Inc.
The 25 mg and 37.5 mg Paroxetine ER tablets are indicated for the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder, the company added.