Zydus receives USFDA approval for Cariprazine Capsules

15 Sep 2022 , 01:34 AM

Zydus Lifesciences US subsidiary Zydus Pharmaceuticals USA Inc has received final approval from the United States Food and Drug Administration USFDA to market Cariprazine Capsules USP 15 mg 3 mg 45 mg and 6 mg USRLD VRAYLAR Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Cariprazine Capsules 15 mg 3 mg 45 mg and 6 mg and thereforeis eligible for 180 days of shared generic drug exclusivity for Cariprazine Capsules 15 mg 3 mg 45 mg and 6 mg Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder The drug will be manufactured at the groups formulation manufacturing facility at Ahmedabad SEZ India Cariprazine Capsules had annual sales of USD 239 bn in the United States according to IQVIA MAT July 2022