Alembic Pharmaceuticals Wins USFDA Approval for Antidepressant Generic

Alembic Pharmaceuticals Ltd received final USFDA approval for its Paroxetine extended-release tablets, a generic version indicated for depression and anxiety treatment. The approval covers 25 mg and 37.5 mg strengths, therapeutically equivalent to Apotex Inc's Paxil CR, targeting major depression, panic, social anxiety, and premenstrual dysphoric disorders.

Devdiscourse News Desk | New Delhi | Updated: 25-09-2025 13:47 IST | Created: 25-09-2025 13:47 IST

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Alembic Pharmaceuticals Ltd has secured final approval from the United States Food and Drug Administration (USFDA) for its generic Paroxetine extended-release tablets, aimed at treating depression and anxiety disorders. This marks a significant milestone in the company's expansion into the US pharmaceutical market.

The regulatory nod pertains to the abbreviated new drug application (ANDA) for Paroxetine tablets in strengths of 25 mg and 37.5 mg. This approval reflects the tablets' therapeutic equivalence to the reference Paxil CR extended-release tablets produced by Apotex Inc.

These Paroxetine tablets are designed to manage conditions such as major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder, broadening the treatment options available for these mental health challenges. Alembic Pharmaceuticals expressed optimism about its potential impact in treating these conditions effectively.