Lupins subsidiary Novel Labs receives US FDA approval for fluocinolone acetonide topical oil

Lupins subsidiary Novel Labs receives US FDA approval for fluocinolone acetonide topical oil

Global pharma major Lupin Limited 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 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.
 
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.

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