Teva’s Weltruza Wins FDA Approval as a Once-Monthly SC Olanzapine Injection for Schizophrenia
Shots:
- The US FDA has approved Weltruza (olanzapine) for extended-release injectable suspension (QM, SC long-acting injectable) for the treatment of schizophrenia in adults, with availability expected in coming wks.
- Trial showed that Weltruza improved schizophrenia symptoms (PANSS), illness severity (CGI-S), and personal & social functioning. It will be available in 318, 425 & 531mg doses without loading doses, oral supplementation or post-injection monitoring
- The EMA has accepted MAA for olanzapine long-acting injectable (TEV-’749) for schizophrenia in adults in May 2026, which is supported by an extensive clinical development program, incl. the P-III (SOLARIS) study
Ref: Globenewswire | Image: Teva | Press Release
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