Posted by Michael Wonder on 24 Sep 2017
Allergan receives refusal to file letter from FDA for Vraylar (cariprazine) supplemental new drug application for the treatment of negative symptoms in schizophrenia
22 September 2017 - Allergan today announced that it received a refusal to file letter from the U.S. FDA regarding its supplemental new drug application for Vraylar (cariprazine) for treatment of negative symptoms associated with schizophrenia in adult patients.
Vraylar is an oral, once daily atypical antipsychotic approved in the US 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, FDA determined that the application for treatment of negative symptoms was not sufficiently complete to permit a substantive review.
