Strides Pharma Science gets FDA approval for Colchicine Tablets generic

Strides Pharma Science Limited said that its Singapore-based stepdown fully-owned subsidiary — Strides Pharma Global Pte. Limited has secured approval for Colchicine Tablets USP, 0.6 mg from the US Food & Drug Administration (USFDA).

Colchicine Tablets USP, 0.6 mg is bioequivalent and therapeutically equivalent to Colcrys Tablets, 0.6 mg, of Takeda Pharmaceuticals U.S.A.

Colchicine tablets are indicated for the treatment and prevention of gout. The drug reduces inflammation which results in pain, swelling, and other symptoms of gout.

Colchicine tablets are approved for the treatment of familial Mediterranean fever (FMF) in adults and children four years or older.

The US market for Colchicine Tablets USP, 0.6 mg is around $85 million, according to IQVIA MAT January 2022 data.

Strides Pharma Science plans to manufacture the drug in Bengaluru with marketing in the US to be done by another subsidiary, Strides Pharma Inc.

The Indian pharma company has a total of 271 ANDA filings with the FDA of which 245 ANDAs have been approved, while the remaining 26 are pending approval. Earlier this year, Strides Pharma Science secured FDA approval for Tamiflu generic.