NEW DELHI: Glenmark Pharmaceuticals announced receipt of final approval from US health regulator for its generic version of Astra Zeneca’s Xylocaine ointment.
The approval given by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc USA (Glenmark) is for Lidocaine Ointment USP, 5 per cent, the company said in a statement.
Citing IMS Health sales data for the 12 month period ending July 2016, the company said Xylocaine Ointment, 5 per cent achieved annual sales of approximately USD 373.0 million.
Glenmark’s current portfolio consists of 109 products authorised for distribution in the US and 62 ANDA’s 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.