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FDA Approves First Once-Monthly Injectable Olanzapine for Schizophrenia Treatment

Human2026-10-10·4 min read
FDA Approves First Once-Monthly Injectable Olanzapine for Schizophrenia Treatment

Teva Pharmaceuticals announced FDA approval of Weltruza (olanzapine extended-release injectable suspension) for the treatment of schizophrenia in adults on October 9, 2026.

Key Details

The medication requires no loading doses, oral supplementation, or post-injection monitoring, based on phase 3 SOLARIS trial data showing efficacy and safety.

Why It Matters

This once-monthly formulation offers improved convenience and potential adherence benefits compared to daily oral antipsychotics for schizophrenia management.

Context

The approval marks the first and only once-monthly subcutaneous injectable olanzapine formulation available in the United States for schizophrenia treatment.

Source: AJMC. This article summarizes the linked reporting and distinguishes announced plans from demonstrated results.