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