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.

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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.

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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.