Granules India announced today that the US Food and 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.
Trazodone tablets are indicated for the treatment of major depressive disorder in adults.
The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health.
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