Teva Pharmaceuticals USA, Inc. and MedinCell S.A. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia. The application included Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia). These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.
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