- Teva Pharmaceutical Industries Ltd's TEVA U.S. affiliate and MedinCell SA MDCLF have received FDA Complete Response Letter (CRL) regarding TV-46000/mdc-IRM for schizophrenia.
- The drug candidate is risperidone extended-release injectable suspension for subcutaneous use.
- Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations.
- Related: Teva Reports Encouraging Data From Late-Stage Schizophrenia Trial.
- The application included Phase 3 data from two pivotal studies that evaluated the efficacy, long-term safety, and tolerability of TV-46000 as a treatment for patients with schizophrenia.
- Price Action: TEVA shares are down 4.42% at $9.73 during the premarket session on the last check Wednesday.
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