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Lupin receives tentative approval for Brexpiprazofe tablets from USFDA


Mumbai, Oct 7: Pharma major Lupin said on Thursday that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, to market 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.
This product will be manufactured at Lupin’s Plthampur facility in India. Brexpiprazole tablets have an estimated annual sales of USD 1258 million in the US (IQVIA MAT July 2021). (UNI)





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