Strides Pharma Science Limited announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Colchicine Tablets USP, 0.6 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Colcrys® Tablets, 0.6 mg, of Takeda Pharmaceuticals U.S.A., Inc. (Takeda).
According to IQVIA MAT January 2022 data, the US market for Colchicine Tablets USP, 0.6 mg is approximately 5 Mn USD. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
Colchicine tablets are used for the treatment and prevention of gout. It reduces inflammation which causes pain, swelling and other symptoms of gout. Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
The company has 271 cumulative ANDA filings with USFDA of which 245 ANDAs have been approved and 26 are pending approval.
