Alembic Pharmaceuticals Secures USFDA Nod for Generic Paroxetine

Alembic Pharmaceuticals Ltd has received final USFDA approval for its generic version of Paroxetine extended-release tablets. These are indicated for treating various mental health conditions, including major depressive disorder and social anxiety disorder. The approval is for the 12.5 mg strength tablets, equivalent to Apotex's Paxil CR Tablets.

Alembic Pharmaceuticals Ltd has announced it has obtained the final approval from the U.S. Food & Drug Administration (USFDA) for its generic Paroxetine extended-release tablets.

The approval pertains to the 12.5 mg strength tablets designed to treat multiple mental health disorders.

This generic version is therapeutically equivalent to Paxil CR Tablets by Apotex Inc.

(With inputs from agencies.)