Glenmark Pharmaceuticals on Monday received final approval from the US health regulator USFDA for its generic version of AstraZeneca's Xylocaine ointment.
The approval given by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc USA (Glenmark) is for Lidocaine Ointment USP, the company said in a statement.
Citing IMS Health sales data for the 12-month period ending July 2016, the company said Xylocaine Ointment market achieved annual sales of approximately $373.0 million.
Glenmark's current portfolio consists of 109 products authorised for distribution in the US and 62 are pending approval with the US FDA.
In addition to these internal filings, Glenmark said it is continuing to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
(With agency inputs)