Glenmark gets USFDA nod for Xylocaine ointment; shares in red

Glenmark Pharmaceuticals announced receipt of final approval from US health regulator 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, 5%, 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% achieved annual sales of approximately $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. 

Glenmark India's shares were trading down on the BSE at Rs 892, down Rs 3.75 or 0.42% from previous close.