Lupin’s wholly-owned subsidiary -- Novel Laboratories Inc. has received approval from the United States Food and Drug Administration (USFDA) 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 U.S. (IQVIA MAT March 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
