Lupin bags USFDA nod for Fluocinolone Acetonide Body Oil
Mumbai: Global pharma major Lupin Limited has 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 Oil, 0.01% (Body Oil).
Fluocinolone Acetonide Oil is 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).
Read also: Lupin Gets CDSCO Panel Nod To study osteoporosis drug Denosumab
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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.
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