FDA approves Teva’s once‑monthly injectable olanzapine (Weltruza) for schizophrenia
Teva Pharmaceutical Industries received U.S. FDA approval for Weltruza™ (olanzapine) extended‑release injectable suspension, the first once‑monthly subcutaneous long‑acting injectable for adult schizophrenia. The decision is based on the Phase 3 SOLARIS trial, which showed symptom improvement, reduced illness severity and tolerability comparable to oral olanzapine. The product will be launched in the United States in the coming weeks in three strengths (318 mg, 425 mg, 531 mg) and requires no loading dose, oral supplementation or post‑injection monitoring.
Why it matters
The approval adds a high‑margin neuroscience product to Teva’s portfolio and could generate $112 million in milestones and royalties, according to the company. The new therapy may improve adherence and expand Teva’s specialty‑medicine revenue base.
Key facts
- 1The FDA approved Weltruza™ (olanzapine) extended‑release injectable suspension for adult schizophrenia on October 9 2026. globenewswire.com
- 2Approval was supported by the pivotal Phase 3 SOLARIS trial, which demonstrated improvement in PANSS scores, reduction in CGI‑S severity and better PSP functioning. globenewswire.com
- 3Weltruza will be available in three strengths: 318 mg, 425 mg and 531 mg, corresponding to daily oral doses of 10 mg, 15 mg and 20 mg. globenewswire.com
- 4The formulation requires no loading doses, no oral supplementation and no post‑injection monitoring. globenewswire.com
- 5Teva plans a U.S. launch in the coming weeks. psychiatrictimes.com
- 6The company estimates the product could generate $112 million in milestones and royalties. calcalistech.com
Summary written by AlphAI AI Desk from 9 of 9 sources. Not investment advice. Figures are as stated by the linked sources.