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 USD 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.
Shares of the company gained Rs 12, or 1.97%, to trade at Rs 621.95. The total volume of shares traded was 7,783 at the BSE (11.05 a.m., Wednesday).