Granules gets USFDA nod for generic gout medication

New Delhi, April 30, 2024.

Drug firm Granules India on Tuesday said it has received approval from the US health regulator to market a medication used to prevent or treat gout attacks.

Granules Pharmaceuticals, Inc, a wholly-owned foreign subsidiary of the company, has received approval from the US Food & Drug Administration (USFDA) for Colchicine Capsules (0.6 mg), it said in a regulatory filing.

The company’s product is therapeutically equivalent to Hikma International Pharmaceuticals LLC’s Mitigare Capsules (0.6 mg), it added.

Colchicine Capsules are indicated for prophylaxis of gout flares in adults.

According to industry sources, the current annual market for Colchicine Capsules in the US is expected to be around USD 55 million.