Granules India receives US FDA’s ANDA approval for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, 300 mg, ET HealthWorld

Hyderabad: Granules India Limited announced that the US Food & Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA) for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC.

Trazodone tablets are indicated for the treatment of major depressive disorder in adults.

Dr Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited, said, “The product will be launched within this quarter and the market share will grow steadily over the next few quarters.”

The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health.