Glenmark’s Linezolid, version of Pfizer’s Zyvox, gets nod from FDA

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Linezolid Tablets, 600 mg, the therapeutic equivalent of Zyvox Tablets, 600 mg of Pharmacia and Upjohn Company, a subsidiary of Pfizer, Inc.

According to IMS Health sales data for the 12 month period ending October 2015, the Zyvox Tablets, 600 mg market1 achieved annual sales of approximately $447.6 million.

Glenmark’s current portfolio consists of 104 products authorized for distribution in the U.S. marketplace and 62 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.