Allergan receives refusal to file letter from FDA for Vraylar
Allergan announced that it received a refusal to file, or RTF letter from the FDA regarding its supplemental new drug application, or sDNA, for Vraylar for treatment of negative symptoms associated with schizophrenia in adult patients. Vraylar is an oral, once daily atypical antipsychotic approved in the U.S. for the treatment of schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder. Upon its preliminary review, the FDA determined that the sNDA for treatment of negative symptoms was not sufficiently complete to permit a substantive review. Cariprazine is approved in Europe for the treatment of schizophrenia. "We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our next steps. Vraylar is an important treatment option for patients suffering from bipolar I disorder and schizophrenia. We remain committed to our mental health program and to cariprazine and its potential as a treatment option for patients suffering from negative symptoms associated with schizophrenia," said David Nicholson CRDO, Allergan.