Vanda Announces FDA Has Accepted for Review the Fanapt Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults

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Vanda Pharmaceuticals Inc. (Vanda)
VNDA
today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Vanda's filing of a supplemental New Drug Application (sNDA) for Fanapt® seeking approval as a maintenance treatment of schizophrenia in adults. Vanda is seeking approval based on the results of the REPRIEVE clinical study, which evaluated the long-term maintenance of efficacy and safety of Fanapt®. The FDA has set a user fee goal date under the Prescription Drug User Fee Act of May 27, 2016, which is the target date for the FDA to complete its review of the sNDA.
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