Lupin gets US FDA nod to market fungal infection cream

The drug is indicated for the treatment of cutaneous candidiasis

Lupin has received final approval from the US health regulator to market its Nystatin and Triamcinolone Acetonide cream used for treatment of a type of fungal infection. The company’s product is is the generic version of Delcor’s Mycolog-II cream. It is indicated for the treatment of cutaneous candidiasis, Lupin said in a filing to the Bombay Stock Exchange.

“The company has received final approval for its Nystatin and Triamcinolone Acetonide cream USP, 100,000 units/gram and 1mg/gram, from the United States Food and Drug Administration (US FDA)…,” it added.

As per IQVIA MAT April 2018 data, Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, had annual sales of around $62.2 million in the US market.