Alembic Pharma Up 3%, Gets Tentative USFDA Nod For Anti-Depression Drug


Shares of Alembic Pharmaceuticals on Wednesday soared 3% on intraday basis, as the drug major for Vilazodone Hydrochloride tablets received tentative approval from USFDA.

The company in its filling to the bourses said that for its ANDA for Vilazodone Hydrochloride tablets, 10 mg, 20 mg and 40 mg, it has received tentative approval from United States Food and Drug Administration (USFDA).

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 a major depressive disorder.

For 12 months ended December 2016, Vilazodone Hydrochloride tablets has an estimated market size of USD 340 million, according to IMS data. The drug firm has total of 54 ANDA approvals from the USFDA.

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