BRIEF—Strides receives US FDA approval for Colchicine Tablets

India’s Strides Pharma Science today announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Colchicine Tablets USP, 0.6mg from the US Food and Drug Administration.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Colcrys tablets, 0.6mg, of Takeda Pharmaceuticals USA, and is a treatment for gout.

According to IQVIA MAT January 2022 data, the US market for Colchicine Tablets USP, 0.6mg is approximately ~$ 85 million.

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.

The company has 271 cumulative abbreviate new drug application (ANDA) filings with US FDA of which 245 ANDAs have been approved and 26 are pending approval.