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U S Food and Drug Administration FDA Accepts Teva s New Drug Application NDA for Olanzapine Extended Release Injectable Suspension TEV 749 for the Once Monthly Treatment of

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PRESS RELEASE December 9 2025 2 00 pm CET Montpellier France Euronext MEDCL

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Treatment adherence remains one of the most persistent challenges in schizophrenia care and formulation matters more than it s often given credit for The FDA has accepted Teva s NDA for

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Risperidone LAI was the first treatment based on BEPO technology to receive FDA approval initially for schizophrenia in April 2023 and subsequently for Bipolar I Disorder in October

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TEV 749 our investigational subcutaneously delivered olanzapine LAI has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once monthly

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FDA acceptance advances TEV 749 an investigational once monthly subcutaneous olanzapine LAI for adult schizophrenia toward potential approval based on a submitted NDA from

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TEV 749 our investigational subcutaneously delivered olanzapine LAI has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once monthly

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Teva Pharmaceuticals announced on December 9 2025 that the company submitted a New Drug Application NDA to the US Food Drug Administration FDA for olanzapine extended

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The innovation of olanzapine LAI comes from its delivery of olanzapine a foundational treatment for schizophrenia as a once monthly subcutaneous formulation said Eric Hughes MD