Glenmark Pharmaceuticals Tuesday said it has received final nod from the US health regulator for its Ranolazine extended-release tablets used for treatment of chronic angina.
Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for Ranolazine extended-release tablets in the strengths of 500 mg and 1,000 mg, the company said in a statement.
The product is a generic version of Gilead Sciences Inc’s Ranexa extended-release tablets in the same strengths, it added.
According to IQVIA sales data for the 12-month period ended May 2019, Ranexa extended-release tablets, 500 mg and 1,000 mg market (which includes brand and all available therapeutic equivalents) achieved annual sales of around USD 929 million, Glenmark said.
The company’s current portfolio consists of 158 products authorised for distribution in the US marketplace and 57 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it …