Alembic Pharma Gets U.S. FDA Nod For Depression Treatment Drug
Drug firm Alembic Pharmaceuticals Ltd. has received final approval from the U.S. Food and Drug Administration for Vilazodone Hydrochloride tablets used for treatment of depression. The launch of the product will be according to the settlement agreement with U.S.-based pharmaceutical firm Allergan Plc.
"The company has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) Vilazodone Hydrochloride tablets, 10 mg, 20 mg, and 40 mg," Alembic Pharma said in an exchange filing on Monday.
Vilazodone Hydrochloride tablets are indicated for the treatment of major depressive disorder. "The approved ANDA is therapeutically equivalent to the reference listed drug product, Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan sales," the filing stated.
Citing IQVIA, the company said hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of $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.