Teva's WELTRUZA wins FDA approval as once-monthly olanzapine injectable for US adults

Teva Pharmaceuticals has secured US Food and Drug Administration approval for WELTRUZA (olanzapine), the company announced on October 9, 2026.

The product is a once-monthly subcutaneous extended-release injectable formulation of olanzapine intended for adults with schizophrenia and, according to Teva, is the first of its kind to deliver olanzapine without loading doses, oral supplementation or post-injection monitoring.

Teva said the approval clears the way for a US launch in the coming weeks in three strengths: 318 mg, 425 mg and 531 mg. Teva told Manufacturing Chemist that the pivotal Phase III SOLARIS trial underpinned the FDA decision.

The company reported that SOLARIS demonstrated symptom improvements, reductions in illness severity and gains in personal and social functioning among trial participants, and it described the systemic safety profile as consistent with that of oral olanzapine. Teva listed weight gain, somnolence and headache among reported adverse events.

The company noted a commercial and development arrangement tied to the product: Teva said it is eligible for mid- to high-single-digit royalties on worldwide net sales of WELTRUZA and could receive up to $112 million in combined development and commercial milestone payments under its deal with Medincell.

Manufacturing Chemist identified WELTRUZA as the second FDA-approved medicine developed using Medincell’s technology, after UZEDY (risperidone) received approval in 2023.

Teva framed WELTRUZA as addressing adherence challenges tied to oral olanzapine, saying that maintaining consistent oral treatment can be difficult for some patients and that inconsistent use can raise the risk of symptom recurrence. The company plans to introduce WELTRUZA to the US market shortly and presented the three dosage strengths as part of that launch strategy.

Safety data Teva cited matched known effects of olanzapine, per the company’s account to Manufacturing Chemist, but the article did not provide detailed numeric results from SOLARIS or independent safety assessments. The report also did not include comments from regulators, clinicians or patient groups beyond Teva’s statements.

Manufacturing Chemist’s coverage of the approval aligns with headlines elsewhere that noted Teva’s FDA win for a monthly injectable olanzapine product.

Reuters, Haaretz and industry outlets also ran headlines reporting Teva’s approval, while Manufacturing Chemist provided the detailed company statements about trial outcomes, product characteristics and the Medincell partnership.