Lupin US FDA approval for Fluocinolone Acetonide Topical Oil

Lupin announced that its wholly-owned subsidiary, Novel Laboratories, based in Somerset, New Jersey, has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic equivalent of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc. This product will be manufactured at Lupin’s Somerset facility in the US.

Fluocinolone Acetonide Topical Oil (RLD Derma-Smoothe/FS) had estimated annual sales of $9 million in the US. (IQVIA MAT Mar 2023).