FDA accepts Teva NDA for olanzapine extended-release injectable suspension

Teva (TEVA) Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Medincell announced that the U.S. Food and Drug Administration has accepted its New Drug Applicationfor olanzapine extended-release injectable suspension for the treatment of schizophrenia in adults. “TEV-‘749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia. Currently, there is no long-acting olanzapine formulation without an FDA-required Risk Evaluation and Mitigation Strategy, which mandates administration in a certified healthcare facility and requires a 3-hour post-injection monitoring period. In the Phase 3 SOLARIS trial, TEV-‘749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring,” the company stated.