New Delhi, March 30 Alembic Pharmaceuticals Ltd announced on Monday that 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 from the US Food & Drug Administration (USFDA) is for the supplemental Abbreviated New Drug Application (sANDA) of Paroxetine extended-release tablets with a strength of 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.
