Alembic Pharmaceuticals Limited 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.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.607.35 as compared to the previous close of Rs. 609.95. The total number of shares traded during the day was 242636 in over 801 trades.
The stock hit an intraday high of Rs. 629 and intraday low of 603.3. The net turnover during the day was Rs. 150528151.