Alembic Pharma receives USFDA nod for tablets treating depression

Alembic Pharma announced that it has received the final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Vilazodone Hydrochloride Tablets, 10 mg, 20 mg and 40 mg. The approved ANDA is equivalent to the reference listed product, Viibryd Tablets, 10 mg, 20 mg and 40 mg of Allergan Sales Limited.

Alembic had previously received a tentative approval for this ANDA and was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and thus, is eligible for 180 days of shared exclusivity. The indicated drug is used for the treatment of major depressive disorder and has an estimated market size of US$ 469 million for twelve months ending September 2019, according to IQVIA.

Alembic Pharmaceuticals engages in developing formulations and Active Pharmaceutical Ingredients (API). The company focuses on anti-infective, analgesic, cough and cold therapies. The company has a cumulative total of 110 ANDA approvals, which include 98 final approvals and 12 tentative approvals from USFDA.

At 12 pm on Monday, the stock is trading at Rs 558.65, down by 0.29 per cent or Rs 1.65 per share. The 52-week high is recorded at Rs 612.75 and the 52-week low is recorded at Rs 435.10.