Granules India Limited announced on Friday 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.
According to the company’s statement, 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.
“We have received the approval within 10 months of filing the application, which is a testament to our strong R&D capabilities. The product will be launched within this quarter and the market share will grow steadily over the next few quarters,” Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited said.
Granules now has 65 ANDA approvals from the US FDA (64 final approvals and 1 tentative approval).
The current annual U.S. market for Trazodone tablets is approximately $128 Million, according to MAT Jun 2024, IQVIA/IMS Health.
