Zydus receives final approval and 180 days shared exclusivity from US FDA for Cariprazine capsules

Zydus Lifesciences’s US subsidiary Zydus Pharmaceuticals (USA) Inc has received final approval from the US Food and Drug Administration (FDA) to market Cariprazine capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg, a company statement notified yesterday.

The statement said that Zydus was one of the first 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 the product, 1.5 mg, 3 mg, 4.5 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 group’s formulation manufacturing facility at Ahmedabad SEZ, it further added.