Teva Pharmaceutical Industries Ltd. (TEVA)'s U.S. affiliate announced that the FDA has accepted its New Drug Application (NDA) for TEV-'749, an extended-release injectable suspension of olanzapine, for the treatment of schizophrenia in adults. This application is supported by late-stage trial data demonstrating the once-monthly subcutaneous injection’s efficacy and safety profile aligns with existing olanzapine formulations, without requiring post-injection monitoring. Following the announcement, shares of TEVA experienced a 1% decline.
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Teva Pharmaceuticals Seeks FDA Greenlight For New Schizophrenia Treatment
Teva Pharmaceutical Industries Ltd. (TEVA)'s U.S. affiliate announced that the FDA has accepted its New Drug Application (NDA) for TEV-'749, an extended-release injectable suspension of olanzapine, for the treatment of schizophrenia in adults. This application is supported by late-stage trial data demonstrating the once-monthly subcutaneous injection’s efficacy and safety profile aligns with existing olanzapine formulations, without requiring post-injection monitoring. Following the announcement, shares of TEVA experienced a 1% decline.