Lupin gets USFDA approval for generic equivalent of Rexulti Tablets
This product would be manufactured at Lupin's Pithampur facility in India.
Mumbai: Pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
Brexpiprazole Tablets are used for the treatment of certain mental and mood disorders. The medicine is a generic equivalent of Rexulti Tablets of Otsuka Pharmaceutical Company Ltd.
This product would be manufactured at Lupin’s Pithampur facility in India. Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of USD 1,575 million in the U.S. (IQVIA MAT December 2022).
Lupin is a 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. It 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 8.7% of its revenue in research and development in FY22.
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