Glenmark Pharma gets US FDA approval for Lidocaine Ointment USP, 5%
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the US FDA for Lidocaine Ointment USP, 5%, the generic version of Xylocaine Ointment, 5% of AstraZeneca.
According to IMS Health sales data for the 12 month period ending July 2016, the Xylocaine Ointment, 5% market achieved annual sales of approximately $ 373.0 million.
Glenmark’s current portfolio consists of 109 products authorized for distribution in the U.S. 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.