Global pharma major Lupin Limited (Lupin) has announced that its wholly-owned subsidiary, Novel Laboratories, 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).