Zydus Worldwide DMCC, a subsidiary of Zydus Lifesciences, has received final FDA approval to market Brexpiprazole tablets, as well as 180 days of shared exclusivity for Brexpiprazole Tablets. Zydus was one of the first applicants to submit a substantially complete ANDA with a paragraph IV certification for Brexpiprazole tablets, making it eligible for 180 days of shared generic drug exclusivity for Brexpiprazole tablets.
Brexpiprazole is an atypical antipsychotic that is used in conjunction with antidepressants to treat major depressive disorder (MDD) in adults. It is also approved for the treatment of schizophrenia in adults and children aged 13 and up. Rexulti tablets contain the reference listed drug brexpiprazole tablet. The drug will be produced at the group’s formulation manufacturing facility in Ahmedabad Special Economic Zone, India.
Zydus Lifesciences is a global lifesciences company focused on discovery that discovers, develops, manufactures, and markets a wide range of healthcare therapies.