Lupin arm gets USFDA nod for Fluocinolone Acetonide Topical Oil

Mumbai: Global pharma major Lupin Limited today announced that the company's 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).

The product is a generic equivalent of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc.

Fluocinolone Acetonide Topical Oil 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).

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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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