Vanda Pharmaceuticals (VNDA) sNDA for Fanapt Approved by U.S. FDA for Schizophrenia

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Vanda Announces FDA Approval of the FanaptĀ® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults

May 26, 2016 4:30 PM EDT

WASHINGTON, May 26, 2016 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Vanda's supplemental New Drug Application (sNDA) for Fanapt®, modifying and expanding the prescribing information (PI) to describe the effectiveness of Fanapt® as a maintenance treatment for schizophrenia in adults. FDA approval was based on the results of the REPRIEVE (Relapse prevention study in patients with schizophrenia) placebo-controlled clinical study which evaluated the long-term maintenance of efficacy and safety of Fanapt®. The study data submitted in the sNDA came from... More