The FINANCIAL — Gedeon Richter Plc and Allergan Plc on June 15 announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug Application (NDA) for cariprazine.
Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, according to Allergan.
The FDA has determined that a recent response to an FDA question about the cariprazine NDA is a “major amendment”, requiring the three-month extension.
“We continue to work with the FDA during their review of the cariprazine NDA. The unmet need of patients suffering with bipolar I disorder and schizophrenia continue to be of paramount importance to Allergan and Richter. We remain committed to pursuing this important treatment option for patients and physicians,” said David Nicholson, Executive Vice President, Global R&D of Allergan.