FDA Approves Teva’s Monthly Weltruza Injection for Adults With Schizophrenia

Teva announced that the U.S. Food and Drug Administration has approved Weltruza, a once-monthly subcutaneous injection of olanzapine for treating schizophrenia in adults. The company said the treatment requires no loading doses, oral supplementation or monitoring after each injection and will become available in the United States in the coming weeks. Approval follows the Phase 3 SOLARIS trial. Teva said its safety profile was consistent with oral olanzapine, with common trial adverse events including weight gain, somnolence, headache, constipation and injection-site reactions. The treatment uses SteadyTeq, a controlled-release copolymer technology proprietary to Medincell.