Alembic Pharma Receives Final Approval For Vilazodone Hydrochloride

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vilazodone 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 Allergan Sales, LLC (Allergan). Vilazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder.

Vilazodone Hydrochloride Tablets, 10 mg, 20 mg, and 40 mg have an estimated market size of US$ 469 million for twelve months ending September 2019 according to IQVIA.-Business Standard