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