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 the major depressive disorder.
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. The launch of this product will be as per settlement agreement with Allergan.
Alembic has a cumulative total of 110 ANDA approvals (98 final approvals and 12 tentative approvals) from USFDA, the pharma company said in the press note.
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.
Alembic Pharmaceuticals Ltd is currently trading at Rs560, up by Rs3.55 or 0.64% from its previous closing of Rs556.45 on the BSE.
The scrip opened at Rs553 and has touched a high and low of Rs566.50 and Rs553 respectively.