Granules Pharma Granted USFDA Approval for Generic Gout Drug

Granules India receives USFDA approval for Colchicine Capsules, used for gout prevention and treatment. The drug is therapeutically equivalent to Hikma's Mitigare Capsules. The US market for these capsules is estimated at USD 55 million annually.

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.