Strides Pharma unit gets US FDA approval for generic product
The company's product, which reduces inflammation and other symptoms of gout, is therapeutically equivalent to Takeda Pharmaceuticals' Colcrys tablets
Strides Pharma Science yesterday said its subsidiary has received approval from the US health regulator to sell colchicine tablets, used for the treatment and prevention of gout, in the American market.
Singapore-based Strides Pharma Global, a step down wholly-owned subsidiary of the company, has received approval from the US Food and Drug Administration (FDA) to market the product, Strides Pharma Science said in a statement.
The company’s product, which reduces inflammation and other symptoms of gout, is therapeutically equivalent to Takeda Pharmaceuticals’ Colcrys tablets.
According to IQVIA MAT January 2022 data, the US market for colchicine tablets USP, 0.6 mg is stood at around $85 million.
Strides said the product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market.
The company has 271 cumulative ANDA filings with FDA, of which 245 ANDAs have been approved and 26 are pending approval, it added.