FDA Approves WELTRUZA, a Once-Monthly Subcutaneous Olanzapine for Schizophrenia

Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved WELTRUZA™ (olanzapine) for extended-release injectable suspension. This new, once-monthly, subcutaneous long-acting injectable (LAI) is approved for the treatment of schizophrenia in adults and is the first and only such formulation of olanzapine requiring no loading doses, oral supplementation, or post-injection monitoring. The approval is based on results from the pivotal Phase 3 SOLARIS trial, which demonstrated overall symptom improvement and significant reduction in illness severity.