Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has received tentative approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for vilazodona hydrochloride tablets, 10 mg, 20 mg and 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Viibryd tablets, 10 mg, 20 mg and 40 mg, of Forest Labs LLC.

Vilazodona 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 Deleware and has stipulated to stay the case in view of the ongoing settlement discussions.

According to IMS, vilazodona hydrochloride tablets have an estimated market size of US$ 340 million for twelve months ending December 2016.

Alembic now has a total of 54 ANDA approvals (47 final approvals and 7 tentative approvals) from the US FDA.