Zydus receives USFDA approval for Brexpiprazole Tablets

Zydus Lifesciences' subsidiary Zydus Worldwide DMCC (Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (USRLD: REXULTI tablets).

Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. It is also indicated for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older . The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Brexpiprazole tablets had annual sales of USD 1,548 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).

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