Alembic gets USFDA nod for Vilazodone Hydrochloride tablets used to treat depression

Drug firm Alembic Pharmaceuticals said it has received a final nod from the US health regulator for Vilazodone Hydrochloride tablets used for treatment of depression. “The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vilazodone Hydrochloride tablets, 10 mg, 20 mg, and 40 mg,” Alembic said in a filing to BSE. Vilazodone Hydrochloride tablets are indicated for the treatment of major depressive disorder.

“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,” the drug firm said. Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019.

Alembic had previously received tentative approval for this ANDA. “Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity,” it said. The launch of the product will be as per settlement agreement with the US-based pharmaceutical firm Allergan.