Glenmark receives US FDA approval for skin ointment lidocaine

The US Food & Drug Administration (FDA) has granted final approval to Glenmark Pharmaceuticals for its skin treatment medication lidocaine ointment USP, 5%. The approved product is the generic version of AstraZeneca’s Xylocaine ointment.

“Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the US FDA for lidocaine ointment USP, 5%, the generic version of Xylocaine Ointment, 5% of AstraZeneca,” said Glenmark in a press statement. 

Lidocaine ointment is used on the skin to stop itching and pain from certain skin conditions such as scrapes, minor burns, eczema, insect bites, etc.

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 million.

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