Lupin on Wednesday said its American subsidiary has received an approval from the US health regulator to market a generic product used for treatment of skin issues. New Jersey-based Novel Laboratories Inc has received the approval from the US Food and Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, Lupin said in a statement.
The product is the generic version of Hill Dermaceuticals Inc's Derma-Smoothe/FS Topical Oil. Lupin said the product will be manufactured at its Somerset facility in the US.
As per the IQVIA MAT March 2023 data, Fluocinolone Acetonide Topical Oil had estimated annual sales of USD 9 million in the US. Lupin shares were trading 0.67 per cent down at Rs 981.65 apiece on the BSE.
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