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Lupin gets US FDA approves for generic Rexulti tablets

Our Bureau, Mumbai
Tuesday, March 21, 2023, 17:15 Hrs  [IST]

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, 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, (Rexulti) had estimated annual sales of USD 1,575 million in the US (IQVIA MAT December 2022).
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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