Lupin receives tentative approval from USFDA for Brexpiprazole Tablets

07 Oct 2021 Evaluate

Lupin 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, 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. This product will be manufactured at Lupin's Pithampur facility In India. Brexpiprazole Tablets (RLD: Rexulti Tablets) had estimated annual sales of $1258 million In the U.S. (IQVIA MAT July 2021).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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