Drug firm Zydus Cadila Thursday said it has received a tentative nod to market generic Colchicine tablets used for prevention and treatment of gout attacks in US market.
The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Colchicine tablets USP in the strength of 0.6 mg, Zydus Cadila said in a statement.
The product is the generic version of Colcyrs tablets in the same strength, it added.
The tablets, “will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad,” it said.
The drug is used to prevent or treat attacks of gout, a condition caused by high uric acid levels in the blood. The medication is also used to treat familial Mediterranean fever.
The group now has 223 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.