New Delhi : Alembic Pharmaceuticals has received tentative approval from the US health regulator for vilazodone hydrochloride tablets used for treatment of depression.
“The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for vilazodone hydrochloride tablets, 10mg, 20mg and 40mg,” Alembic Pharma said in a BSE filing.
The approved product is therapeutic equivalent to the reference-listed drug product Viibryd tablets of Forest Labs LLC.
Alembic Pharma is 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.
The tablets are indicated for treatment of major depressive disorder, it said.
These tablets have an estimated market size of USD 340 million for 12 months to December 2016, according to IMS.
Alembic Pharma has a total of 54 ANDA approvals from the US health regulator.