Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults

PARSIPPANY, N.J. and TEL AVIV, Israel, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia.¹ The results validated olanzapine LAI in meeting efficacy and safety endpoints in a broad adult population of people living with schizophrenia.

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