Teva reports FDA approval of monthly subcutaneous olanzapine formulation
Company / institutional announcement · Teva
Source published: · Event / reporting date: 2026-10-09
Site published: 2026-11-03 · Updated: 2026-11-03
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What changed
Teva announced FDA approval of WELTRUZA, a monthly subcutaneous extended-release olanzapine suspension for adults with schizophrenia. The formulation uses Medincell’s SteadyTeq copolymer technology and requires no loading dose, oral supplementation, or post-injection monitoring. Supported by the Phase 3 SOLARIS trial, it retains important olanzapine safety considerations, including weight gain and metabolic effects, rather than eliminating systemic drug risks.
Why it may matter
The approval illustrates how controlled-release materials and administration route can differentiate established molecules, creating opportunities for complex injectable development and manufacturing.
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