Strides Pharma Science Ltd. announced on Friday that Stepdown’s wholly owned subsidiary, Strides Pharma Global Pte Ltd., Singapore, has received US FDA approval for Colchicine USP 0.6mg Tablets for the treatment and prevention of gout.
The approved product is bioequivalent and therapeutically equivalent to the referenced drug Colcrys Tablets 0.6mg by Takeda Pharmaceuticals USA, Inc. It is manufactured at Strides’ Bengaluru facility and marketed in the United States by Strides Pharma Inc.
The US market for colchicine tablets USP, 0.6 mg, is about $85 million, the company said, citing January 2022 data from IQVIA MAT. Strides said there were 271 cumulative ANDA filings at from the US FDA, of which 245 ANDAs have been approved and 26 are awaiting approval.