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Glenmark gets USFDA nod to clobetasol propionate foam


Glenmark gets USFDA nod to clobetasol propionate foam

The approval has been granted by the United States Food and Drug Administration (USFDA) to Glenmark Pharmaceuticals, US, for clobetasol propionate foam, 0.05 per cent, a generic version of Olux Foam, 0.05 per cent, of Mylan Pharmaceuticals, the company said in a statement.

New Delhi: Glenmark Pharmaceuticals Monday said it has received final approval from the US health regulator for its generic version of clobetasol propionate foam, a steroid used to treat inflammation and itching of the skin.

The approval has been granted by the United States Food and Drug Administration (USFDA) to Glenmark Pharmaceuticals, US, for clobetasol propionate foam, 0.05 per cent, a generic version of Olux Foam, 0.05 per cent, of Mylan Pharmaceuticals, the company said in a statement.

Clobetasol propionate is a corticosteroid of the glucocorticoid class used to treat various skin disorders including eczema and psoriasis. It is also highly effective for contact dermatitis caused by exposure to poison ivy/oak.

Clobetasol propionate is used cosmetically by dark-skinned women for skin whitening, although this use is controversial. The U.S. Food and Drug Administration has not approved it for that purpose, and sales without a prescription are illegal in the U.S.

Also Read: Glenmark Pharma gets USFDA nod for drug for patients on dialysis

Citing IQVIA sales data, Glenmark said, Olux foam 0.05 per cent achieved annual sales of approximately $50.9 million in the 12-month period ended December 2018.

The company said its current portfolio consists of 150 products authorised for distribution in the US and 52 ANDA’s pending approval with the USFDA.

Glenmark Pharmaceuticals is headquartered in Mumbai. The company was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer.

Also Read: Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant

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Source: with inputs
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