Lupin gets USFDA nod to market fungal infection cream
New Delhi: Drug firm Lupin said it has received final approval from the US health regulator to market its Nystatin and Triamcinolone Acetonide cream used for the 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 BSE.
"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 (USFDA)...," 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 USD 62.2 million in the US market.
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