Zydus Cadila receives tentative approval from US FDA for Cariprazine Capsule

Zydus Pharmaceuticals Inc has received tentative approval from the United States Food and Drug Administration (FDA) to market Cariprazine Capsules in the strengths of 1.5 mg, 3 mg, 4.5 mg and 6 mg, the company notified via a statement.

It also said that Cariprazine is an atypical antipsychotic. Zydus’ Cariprazine Capsules are indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.