FDA to Review Fanapt Expanded Indication in Schizophrenia
Vanda Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Fanapt (Iloperidone) seeking approval as a maintenance treatment of schizophrenia in adults.
The sNDA submission is based on results of the REPRIEVE clinical study, which evaluated the efficacy and safety of long-term maintenance with Fanapt.
Fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adult patients.
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