Alembic Pharma gets tentative approval from USFDA for Vilazodone Hydrochloride Tablets

19 Apr 2017 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vilazodone Hydrochloride Tablets, 10mg, 20mg and 40mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Viibryd Tablets, 10 mg, 20mg and 40mg, of Forest Labs LLC. Vilazodone Hydrochloride Tablets are indicated for the treatment of Major Depressive Disorder (MDD). Alembic is currently in litigation with Forest Labs LLC in District Court of Delaware and has stipulated to stay the case in view of the ongoing settlement discussions.

Vilazodone Hydrochloride Tablets have an estimated market size of $340 million for twelve months ending December 2016 according to IMS. Alembic now has a total of 54 ANDA approvals (47 final approvals and 7 tentative approvals) from the USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.

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