Lupin Limited said that their wholly-owned US subsidiary, Novel Laboratories Inc., has secured approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Fluocinolone Acetonide Oil, 0.01% (Body Oil). This product stands as the generic counterpart to DermaSmoothe/FS 0.01% (Body Oil) originally by Hill Dermaceuticals, Inc.

Commercial Impact and Production Details:

The market value of Fluocinolone Acetonide Oil, tracing back to its reference listed drug Derma-Smoothe/FS®, was approximated at annual sales of USD 10 million in the U.S. as per IQVIA MAT June 2023 figures. Reinforcing the announcement’s significance, Lupin divulged that the production of this approved product will be overseen at their dedicated Somerset facility in the US.

  Hill Dermaceuticals, Lupin, Novel Laboratories, US FDA, US Food and Drug Administration