TEV-749 is an investigational once-monthly subcutaneous long-acting injectable formulation of olanzapine being developed for adults with schizophrenia. Teva announced FDA acceptance of its NDA in February 2026 based on Phase 3 SOLARIS data. The candidate is under regulatory review and has not been approved at this time.
Teva and Sanofi reported durable 44-week efficacy for duvakitug in inflammatory bowel disease, while the FDA accepted Teva's application for TEV-749, a once-monthly olanzapine injection for schizophrenia.
The FDA has accepted Teva Pharmaceuticals' New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine injection for treating schizophrenia in adults, based on Phase 3 trial data showing efficacy consistent with existing formulations without requiring post-injection monitoring.
The FDA has accepted Teva and Medincell's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine formulation for schizophrenia treatment that showed no need for post-injection monitoring in Phase 3 trials.
The FDA has accepted Teva and Medincell's New Drug Application for olanzapine extended-release injectable suspension (TEV-'749), a once-monthly subcutaneous treatment for schizophrenia in adults that showed no evidence for post-injection monitoring requirements.
The FDA has accepted Teva Pharmaceutical's New Drug Application for TEV-'749, a once-monthly subcutaneous olanzapine extended-release injectable suspension for treating schizophrenia in adults, supported by Phase 3 SOLARIS trial data.