FDA Approves Teva’s Once-Monthly Injectable Olanzapine For Adults With Schizophrenia

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) approved WELTRUZA (olanzapine) extended-release injectable suspension for treating schizophrenia in adults. The once-monthly subcutaneous injection is expected to be available in the United States in the coming weeks in three strengths: 318 milligrams (mg), 425 mg, and 531 mg. The product does not require a loading dose, oral supplementation, or post-injection monitoring.

In the Phase 3 SOLARIS trial, all three doses had similar tolerability. The most commonly reported adverse events included weight gain, somnolence, headache, constipation . . .