Global pharma major Lupin Limited (Lupin) 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 (FDA) for its Abbreviated New Drug Application for fluocinolone acetonide oil, 0.01% (body oil), a generic equivalent of Derma-Smoothe/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 (Derma-Smoothe/FS) had estimated annual sales of USD 10 million in the US (IQVIA MAT June 2023).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
