Alembic Pharma Gets USFDA Nod for Mental Health Tablet

New Delhi, Mar 30 (PTI) Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Paroxetine extended-release tablets indicated for various mental health conditions.

The approval by the US Food & Drug Administration (USFDA) is for the supplemental Abbreviated New Drug Application (sANDA) of Paroxetine extended-release tablets of strength 12.5 mg, Alembic Pharmaceuticals said in a statement.


The approved sANDA is therapeutically equivalent to the reference-listed drug product Paxil CR Tablets, 12.5 mg, of Apotex Inc, it added.

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), the company said.