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# Allergan Gets ‘Refuse-to-File’ on Schizophrenia Drug
- URL: https://www.fdaweb.com/allergan-gets-refuse-to-file-on-schizophrenia-drug/
- Published: 2017-09-27T12:00:00.000Z
- Updated: 2026-09-14T22:52:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139730

FDA has issued Allergan a refuse-to-file letter on a supplemental NDA for Vraylar (cariprazine) for treating negative symptoms associated with schizophrenia in adult patients. The oral, once daily atypical antipsychotic is currently approved in the U.S. for treating schizophrenia and the acute treatment of adult patients with manic or mixed episodes associated with Bipolar 1 disorder. After a preliminary review, the agency determined that the submission was not sufficiently complete to permit a substantive review, the company says.