Moneycontrol
Apr 19, 2017 11:15 AM IST | Source: Moneycontrol.com

Alembic Pharma up 3%, gets tentative USFDA nod for anti-depression drug

The approved ANDA is therapeutically equivalent to the reference listed drug product Viibryd tablets, 10 mg, 20 mg and 40 mg of Forest Labs In

Alembic Pharma up 3%, gets tentative USFDA nod for anti-depression drug

Moneycontrol News

Shares of Alembic Pharmaceuticals advanced 3 percent intraday Wednesday as it has received tentative approval from USFDA for Vilazodone Hydrochloride tablets.

“The company has received tentative approval from United States Food and Drug Administration (USFDA) for its ANDA for Vilazodone Hydrochloride tablets, 10 mg, 20 mg and 40 mg," as per company release.

The approved ANDA is therapeutically equivalent to the reference listed drug product Viibryd tablets, 10 mg, 20 mg and 40 mg of Forest Labs Inc.

Vilazodone Hydrochloride tablets are indicated for the treatment of major depressive disorder.

According to IMS data, Vilazodone Hydrochloride tablets have an estimated market size of USD 340 million for 12 months ended December 2016.

Alembic now has total of 54 ANDA approvals from the USFDA.

At 11:05 hrs Alembic Pharmaceuticals was quoting at Rs 621.95, up Rs 12, or 1.97 percent on the BSE.

Posted by Rakesh Patil
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