Lupin receives approval from U.S. FDA for Fluocinolone Acetonide Body Oil

Global pharma major Lupin Limited (Lupin) has announced that its wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Fluocinolone Acetonide Oil, 0.01% (Body Oil), a generic equivalent of DermaSmoothe/FS® 0.01% (Body Oil), of Hill Dermaceuticals, Inc. This product will be manufactured at Lupin's Somerset facility in the US.

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1083.85 as compared to the previous close of Rs. 1081.40. The total number of shares traded during the day was 74709 in over 4712 trades.

The stock hit an intraday high of Rs. 1094.70 and intraday low of 1071.20. The net turnover during the day was Rs. 80958022.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 NovelLaboratories USFDA Approval ANDA FluocinoloneAcetonideOil