USFDA approves Lupin's Brexpiprazole tablets for schizophrenia and depression, Health News, ET HealthWorld
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USFDA approves Lupin's Brexpiprazole tablets for schizophrenia and depression
The Brexpiprazole tablets are the generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company Ltd, an atypical antipsychotic indicated as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and for treating schizophrenia in adults and pediatric patients ages 13 years and older.
ETHealthWorld
March 22, 2023, 10:33 IST
Mumbai: Lupin Limited has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The tablets will be manufactured at Lupins Pithampur facility in India.
The Brexpiprazole tablets are the generic equivalent of Rexulti tablets of Otsuka Pharmaceutical Company Ltd, an atypical antipsychotic indicated as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and for treating schizophrenia in adults and pediatric patients ages 13 years and older.
Brexpiprazole tablets had an estimated annual sales of $1,575 million in the US as per IQVIA MAT December 2022.
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Wednesday, March 22, 2023 at 5:03 am