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Lupin gets USFDA approval for generic equivalent of Rexulti Tablets
This product would be manufactured at Lupin's Pithampur facility in India.
Mumbai: Pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
Brexpiprazole Tablets are used for the treatment of certain mental and mood disorders. The medicine is 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, (RLD Rexulti) had estimated annual sales of USD 1,575 million in the U.S. (IQVIA MAT December 2022).
Read also: Lupin alliance partner Caplin Steriles bags USFDA okay for Thiamine Hydrochloride Injection
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751