Global pharma major Lupin Limited on Wednesday 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 Topical Oil, 0.01% (Scalp Oil).
According to the company’s statement, it is a generic equivalent of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc.
Fluocinolone acetonide is a corticosteroid primarily used in dermatology to reduce skin inflammation and relieve itching.
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 USD 9 million in the U.S. (IQVIA MAT Mar 2023).
