FDA Approves Teva’s Once-Monthly Injectable Olanzapine WELTRUZA for Adult Schizophrenia

PARSIPPANY, N.J., Oct. 9 (TodayViralUSA) — The U.S. Food and Drug Administration has approved Teva Pharmaceuticals’ WELTRUZA (olanzapine) for extended-release injectable suspension, the company said Friday, clearing the first once-monthly subcutaneous long-acting formulation of the widely used antipsychotic for adults with schizophrenia.

Teva said the product will be offered in 318 mg, 425 mg and 531 mg strengths corresponding to daily oral olanzapine doses of 10 mg, 15 mg and 20 mg. Unlike some long-acting injectables, WELTRUZA requires no loading doses, no oral supplementation and no mandatory post-injection observation period, the company said, with U.S. availability expected in the coming weeks.

Olanzapine has been a foundational oral treatment for schizophrenia for more than three decades, but daily pills can be hard to sustain. Teva framed the injectable as a way to maintain therapeutic levels while reducing adherence barriers that contribute to relapse and hospitalization.

SOLARIS trial underpins approval

The approval rests on the Phase 3 SOLARIS study, which Teva said showed overall symptom improvement on the PANSS scale, significant reductions in illness severity on CGI-S, and gains in personal and social functioning on the PSP scale. The systemic safety profile was described as consistent with oral olanzapine; common adverse events included weight gain, somnolence, headache, constipation and injection-site reactions.

Chris Fox, Teva’s U.S. commercial chief, called the approval a fill for “a major, long-standing gap in the schizophrenia treatment landscape.” Chief Medical Officer Eric Hughes said the subcutaneous design was intended to remove monitoring barriers that have limited use of earlier intramuscular long-acting olanzapine products.

Christoph Correll, a psychiatry professor at the Zucker School of Medicine at Hofstra/Northwell, said a monthly subcutaneous option that reaches therapeutic blood levels without oral cotreatment or booster injections “can help empower patients” and give clinicians another tool against a complex illness.

Safety warnings remain central

As with other antipsychotics, WELTRUZA carries boxed warnings, including an increased risk of death in elderly patients with dementia-related psychosis, for whom the drug is not indicated. Labeling also addresses metabolic changes, weight gain, orthostatic hypotension, tardive dyskinesia and the theoretical risk of post-injection delirium/sedation syndrome — a known concern with intramuscular extended-release olanzapine that Teva says has not been established for this subcutaneous formulation.

About 2.1 million people in the United States are currently diagnosed with schizophrenia, Teva cited. The European Medicines Agency accepted a marketing application for the same long-acting candidate in May 2026; it is not yet approved in Europe.