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Glenmark OKd by USFDA for generic of Ranexa

Glenmark Pharmaceuticals got the final approval by the US FDA for its Ranolazine Extended-Release Tablets, generic version of Gilead’s Ranexa.

The approval is for 500 mg and 1,000 mg, Extended-Release Tablets, 500 mg and 1,000 mg, Glenmark said Tuesday in a press release.

Referring to the data collected by IQVIA, Glenmark said that the sales data for the 12 month period ending May 2019, the Ranexa Extended-Release Tablets, 500 mg and 1,000 mg market achieved annual sales of approximately $929.0 million.

Glenmark’s current portfolio consists of 158 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the U.S. FDA, it noted. In addition to these internal filings, Glenmark said it continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

RANEXA is indicated for the treatment of chronic angina.

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