Glenmark receives USFDA approval for generic version of Xylocaine ointment

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Lidocaine Ointment USP, 5%, the generic version of Xylocaine Ointment, 5% of AstraZeneca. The Xylocaine Ointment, 5% market achieved annual sales of approximately $373.0 million, according to IMS Health sales data for the twelve month period ending July 2016.

The pharma major has been recently granted final approval by the USFDA for Triamcinolone Acetonide Cream USP, 0.1%, the generic version of Kenalog Cream, 0.1% of Delcor Asset Corporation (which is no longer being marketed in the United States).

Glenmark’s current portfolio consists of 109 products authorized for distribution in the US marketplace and 62 ANDA’s pending approval with the US 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.