Lupin gets tentative nod from USFDA for generic Locoid Lotion

12 Feb 2018 Evaluate

Lupin has received tentative approval for its Hydrocortisone Butyrate Lotion, 0.1% from the United States Food and Drug Administration (USFDA) to market a generic version of Precision Dermatology, Inc.'s Locoid Lotion, 0.1%. Hydrocortisone Butyrate Lotion, 0.1% had annual sales of around $16.1 million in the US (IQVIA MAT October 2017).

The company’s Hydrocortisone Butyrate Lotion, 0.1% is the generic equivalent of Precision Dermatology, Inc.'s Locoid Lotion, 0.1%. It is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

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