The application was based on data from a late-stage trial in which TEV-‘749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations.
U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA) said on Friday that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension or TEV-‘749 for the treatment of schizophrenia in adults.
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The application was based on data from a late-stage trial in which TEV-‘749 administered as a once-monthly subcutaneous injection demonstrated an efficacy and safety profile consistent with currently available olanzapine formulations and showed no evidence for the need for post-injection monitoring.
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