Zydus Lifesciences US arm bags USFDA nod for schizophrenia drug Cariprazine
Cariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder.;
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Ahmedabad: Zydus Lifesciences Limited's (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received final approval from the United States Food and Drug Administration (USFDA) to market Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg (USRLD: VRAYLAR).
Zydus was one of the first Abbreviated New Drug Application (ANDA) applicants to submit a substantially complete ANDA with a paragraph IV certification for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg.
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