Teva's Olanzapine Injectable Suspension Gains FDA Nod

The U.S. FDA has accepted Teva Pharmaceuticals' New Drug Application (NDA) for their olanzapine extended-release injectable suspension, known as TEV-'749. This once-monthly treatment for schizophrenia aims to improve patient adherence and long-term stability.

Currently, no long-acting olanzapine formulation exists without a Risk Evaluation and Mitigation Strategy (REMS). The Phase 3 SOLARIS trial results indicated TEV-'749 showed effectiveness and safety comparable to existing options, potentially eliminating the need for post-injection monitoring.

Teva highlights the unmet need for long-acting olanzapine solutions, especially given that daily oral olanzapine is widely used. Medincell, in collaboration with Teva, uses its proprietary SteadyTeq™ technology for sustained olanzapine release, enhancing treatment effectiveness.