Actavis Resubmits Cariprazine Approval Application to FDA

The FDA has acknowledged receipt of Actavis's resubmitted New Drug Application for its investigational atypical antipsychotic, cariprazine, which is indicated for the treatment of patients with schizophrenia and manic or mixed episodes associated with bipolar I disorder.

The FDA has acknowledged receipt of Actavis’s resubmitted New Drug Application (NDA) for its investigational atypical antipsychotic, cariprazine, which is indicated for the treatment of patients with schizophrenia and manic or mixed episodes associated with bipolar I disorder.

“We believe the resubmission of the cariprazine NDA includes the necessary data to address FDA’s comments and continue the review of this innovative treatment option,” said David Nicholson, senior vice president of global brands R&D at Actavis, in a press release. “We are committed to the mental health community and this promising treatment option to address patients’ medical needs.”

Cariprazine’s safety and efficacy was examined in a clinical trial that enrolled more than 2700 patients. The atypical antipsychotic is also being investigated for the treatment of bipolar depression and as an adjunctive treatment for major depressive disorder in adults.

Actavis expects the FDA to act on the cariprazine NDA in the second quarter of 2015.