Lupin Brexpiprazole tablets bags USFDA okay
Mumbai: Global pharma major Lupin Limited has recently announced that the company has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
The product is a generic equivalent of Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical Co., Ltd.
Brexpiprazole is used in the treatment of schizophrenia and as an adjunct for major depressive disorder.
This product will be manufactured at Lupin's Pithampur facility in India.
Brexpiprazole Tablets (RLD: Rexulti Tablets) had estimated annual sales of USD 1258 million in the U.S. (IQVIA MAT July 2021).
Headquartered in Mumbai, India, Lupin 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
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