Glenmark Pharmaceuticals receives USFDA tentative approval for Axitinib Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Axitinib Tablets, 1 mg and 5 mg, the generic version of Inlyta1 Tablets, 1 mg and 5 mg, of PF Prism C.V.

According to IQVIATM sales data for the 12 month period ending October 2020, the Inlyta Tablets, 1 mg and 5 mg market achieved annual sales of approximately $518.8 million.

Glenmark's current portfolio consists of 166 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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