Granules India Gets USFDA Approval for Generic Gout Medication
Apr 30, 2024 11:31
Granules India receives USFDA approval to market Colchicine Capsules (0.6 mg) for gout prevention and treatment. The generic medication is therapeutically equivalent to Hikma International Pharmaceuticals's Mitigare Capsules.
New Delhi, Apr 30 (PTI) 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.
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