Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia
Teva Pharmaceutical Industries Limited American Depositary Shares (TEVA)
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Source: Business Wire
File acceptance marks important milestone for Teva’s commitment to treatments for mental disorders PARSIPPANY, N.J., TEL AVIV & PARIS--(BUSINESS WIRE)--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration (FDA).The acceptance is based on 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. Results will be shared at future scientific conferen
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