Drug firm Granules India on Tuesday said it has received tentative approval from the US health regulator for its generic Colchicine capsules indicated for prevention of gout flares in adults.
The US Food and Drug Administration (USFDA) has tentatively approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals Inc for Colchicine capsules in the strength of 0.6 mg, Granules India said in a filing to the BSE.
The company's product is a generic version of Hikma International Pharmaceuticals LLC's Mitigare capsules in the same strength, it added.
"We are pleased to receive tentative approval for our fourth Paragraph IV ANDA and launch of the product will be as per our agreement with Hikma Pharmaceuticals USA Inc," Granules Pharmaceuticals Inc ED Priyanka Chigurupati said.
According to IQVIA Health data, the Mitigare brand and generic had US sales of around $ 84 million MAT for the 12 months ended December 2019, Granules India said.
Shares of Granules India were trading at Rs 163.80 per scrip on the BSE, down 0.73 per cent from the previous close.