FDA Accepts Teva's Application for Once-Monthly Schizophrenia Injectable
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.
Teva Pharmaceutical and Medincell announced that the U.S. Food and Drug Administration has accepted their New Drug Application for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. The FDA acceptance was confirmed on February 20, 2026.
The NDA is supported by Phase 3 SOLARIS Week 56 results showing efficacy and safety consistent with existing olanzapine formulations and no evidence requiring post-injection monitoring. TEV-'749 is designed as a once-monthly subcutaneous injection to improve real-world treatment adherence and help patients maintain long-term stability.
The investigational therapy uses Medincell's SteadyTeq sustained-release copolymer technology. The SOLARIS trial population was limited to ages 18 to 64. TEV-'749 is not currently approved by any regulatory authority.
In December 2025, Teva Pharmaceuticals filed the New Drug Application with the FDA for olanzapine long-acting injectable, emphasizing its commitment to working with the FDA to meet unmet needs in schizophrenia care while strengthening its position in the innovative medicine sector. The company stated that olanzapine long-acting injectable suspension has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation.
If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations. The company is committed to advancing this innovative treatment option and further building on its differentiated long-acting injectable franchise and scientific leadership in complex neurological conditions as it drives forward its Pivot to Growth strategy.
Teva Pharmaceutical Industries Ltd, based in Israel, is the leading generic drug manufacturer in the world. Teva derives half of its sales from North America and makes up a high-single-digit percentage of the total number of generic prescriptions in the US. Besides generics, Teva has a portfolio of innovative medicines and biosimilars in three main therapeutic areas: the central nervous system with Copaxone, Ajovy, and Austedo; respiratory with Qvar and ProAir; and oncology with Truxima, Herzuma, and Bendeka/Treanda.