Granules India has received an approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals Inc. (GPI), a wholly owned foreign subsidiary of the company for Colchicine capsules.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mitigare capsules of Hikma International Pharmaceuticals LLC (Hikma).
Colchicine capsules are indicated for prophylaxis of gout flares in adults. With this, Hyderabad-based Granules now has a total of 64 ANDA approvals from the USFDA (63 Final approvals and one tentative approvals).
The current annual U.S. market for Colchicine capsules is approximately $55 million in February 2024, according to industry estimates, the company said in a release.