FDA Accepts Teva’s New Drug Application For Olanzapine Extended-Release Injectable Suspension For The Once-Monthly Treatment Of Schizophrenia In Adults

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Medincell announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. In clinical trials, 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. The medication is intended to help people diagnosed with schizophrenia maintain long-term stability.

Currently, there is no long-acting . . .