Teva, MedinCell Say FDA Accepts NDA for Schizophrenia Treatment

By Stephen Nakrosis

Teva Pharmaceuticals and MedinCell on Tuesday said the U.S. Food and Drug Administration accepted their new drug application for TV-46000/mdc-IRM to treat schizophrenia.

The companies said the acceptance of TV-46000/mdc-IRM, or risperidone extended-release injectable suspension for subcutaneous use, was based on Phase 3 data from two studies which "evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia." The companies said the results will be shared "at future scientific conferences and in peer-reviewed publications."

Teva will continue to lead the clinical development and regulatory process and will be responsible for commercialization, while MedinCell will be eligible for certain milestones and royalties, the companies said.

Teva Pharmaceuticals is a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

August 31, 2021 16:56 ET (20:56 GMT)

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