New Delhi: Drug firm Granules India on Tuesday said it has received approval from the US health regulator to market a drug used to prevent or treat arthritis attacks.
The company's wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc., has received approval from the US Food and Drug Administration (USFDA) for Colchicine Capsules (0.6 mg), a regulatory filing said.
It said the company's product is therapeutically equivalent to Hikma International Pharmaceuticals LLC's Mitigare capsules (0.6 mg).
Colchicine capsules are indicated for the prevention of gout flares in adults.
According to industry sources, the current annual market for colchicine capsules in the US is expected to be around US$55 million.
The company's wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc., has received approval from the US Food and Drug Administration (USFDA) for Colchicine Capsules (0.6 mg), a regulatory filing said.
It said the company's product is therapeutically equivalent to Hikma International Pharmaceuticals LLC's Mitigare capsules (0.6 mg).
Colchicine capsules are indicated for the prevention of gout flares in adults.
According to industry sources, the current annual market for colchicine capsules in the US is expected to be around US$55 million.
