Last Updated : Monday, January 13, 2020 17:14:43

ALEMBIC PHARMA gets USFDA nod to market depressive disorder treatment

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Vadodara (Baroda) headquartered India pharmaceutical major – Alembic Pharmaceuticals receives USFDA Final Approval for drug Vilazodone Hydrochloride Tablets in 10 mg. 20 mg, and 40 mg dosage, which is used to treat depressive disorder and had a one year market size equivalent to USD $469 million for twelve months ended on September 2019.

The press-release titled, “Alembic Pharmaceuticals receives USFDA Final Approval for Vilazodone Hydrochloride Tablets, 10 mg. 20 mg, and 40 mg.”, further read that, Alembic Pharmaceuticals Limited (Alembic) today announced that the Company 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 (Abbreviated New Drug Application) 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.

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.

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