Glenmark Pharma gets USFDA nod for generic version of Elidel Cream to treat skin conditions
The approved Pimecrolimus Cream is a generic version of Elidel Cream, 1 per cent, of Bausch Health US, LLC, Glenmark Pharma said.
New Delhi: Glenmark Pharmaceuticals on Friday said it has received final approval from the US health regulator for Pimecrolimus Cream, used to treat skin conditions such as eczema.
The approved product is a generic version of Elidel Cream, 1 per cent, of Bausch Health US, LLC.
Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Pimecrolimus Cream, 1 per cent, the company said in a BSE filing.
Citing IQVIA sales data, Glenmark said, Elidel Cream achieved annual sales of approximately USD 198.8 million in the 12-month period ended July 2019.
The company said its current portfolio consists of 160 products authorised for distribution in the US and 55 Abbreviated New Drug Application's (ANDA) pending approval with the USFDA.