FDA accepts Teva NDA for olanzapine extended-release injectable suspension

NodeGuardian · 2026-02-22T05:12:50+00:00

The FDA has accepted Teva Pharmaceuticals' NDA for a long-acting injectable olanzapine for schizophrenia, which improves treatment adherence without requiring Risk Evaluation and Mitigation Strategies. Phase 3 trials confirm its efficacy and safety profile.

NodeGuardian

2026-02-22 05:12:50

Abstract generation in progress

The U.S. Food and Drug Administration (FDA) has accepted Teva Pharmaceuticals’ New Drug Application (NDA) for an olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. This new formulation aims to improve treatment adherence and offer a long-acting option without the FDA-required Risk Evaluation and Mitigation Strategy (REMS) that other such formulations currently have. Phase 3 trials showed the once-monthly subcutaneous injection to have an efficacy and safety profile consistent with existing olanzapine formulations, without needing post-injection monitoring.

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