PARSIPPANY, NJ, TEL AVIV & PARIS – Teva Pharmaceuticals, US subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) today announce that the U.S. Food and Drug Administration (“FDA”) has issued a Comprehensive Response Letter (CRL) regarding the New Drug Administration (NDA) filing. for TV-46000/mdc-IRM (risperidone subcutaneous injectable suspension extended release) indicated for the treatment of schizophrenia.
Teva and MedinCell remain committed to developing risperidone and making the product available as quickly as possible to US patients. Based on this letter, Teva is preparing next steps and will work closely with the FDA to respond to its recommendations.
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 long-term efficacy, safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.