Alembic Pharma gets USFDA nod for depression drug Vilazodone Hydrochloride tablets

"The approved ANDA (Vilazodone Hydrochloride tablets) is therapeutically equivalent to the reference listed drug product (RLD), Viibryd tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales," Alembic Pharma said.

New Delhi: Drug firm Alembic Pharmaceuticals on Monday said it has received a final nod from US health regulator for Vilazodone Hydrochloride tablets used for the treatment of depression.

"The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vilazodone Hydrochloride tablets, 10 mg, 20 mg, and 40 mg," Alembic said in a filing to BSE.

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

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"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," the drug firm said.

Citing IQVIA, the company said Hydrochloride tablets, 10 mg, 20 mg, and 40 mg, have an estimated market size of USD 469 million for 12 months ending September 2019.

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