FDA Accepts Teva-MedinCell NDA For Schizophrenia Drug

The U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) submitted by Teva and MedinCell for a drug to treat schizophrenia. The NDA is for TV-46000/mdc-IRM, a risperidone extended-release injectable suspension for subcutaneous use. Teva will continue to lead the clinical development and regulatory process and be responsible for commercialization of this candidate treatment, with MedinCell eligible for development milestones, royalties on net sales and future commercial milestones.

The FDA’s acceptance is based on Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended . . .