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Lupin receives tentative approval from U.S. FDA for Brexpiprazole Tablets

Brexpiprazole Tablets (RLD: Rexulti Tablets) had estimated annual sales of USD 1258 million in the U.S.

by Ameen Syed
Lupin receives tentative approval from U.S. FDA for Brexpiprazole Tablets

Global pharma major Lupin Limited (Lupin) announced 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 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). 

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 U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.