The U.S. Food and Drug Administration accepted Teva Pharmaceutical Industries’ New Drug Application for the once‑monthly olanzapine extended‑release injectable suspension (TEV‑749) on February 20 2026. The acceptance clears the drug for the next phase of review and removes a regulatory hurdle that had delayed the product’s launch by 18 months.
The NDA, filed jointly with Medincell, is based on the Phase 3 SOLARIS trial, which demonstrated efficacy and safety comparable to existing olanzapine formulations and showed no need for post‑injection monitoring. TEV‑749 uses Medincell’s SteadyTeq™ copolymer technology to deliver a steady, subcutaneous release of olanzapine once a month, potentially eliminating the FDA‑required REMS program that currently mandates a three‑hour post‑injection observation period for the only other long‑acting olanzapine product.
"Treatment adherence remains a major challenge and unmet need for people living with schizophrenia, including many who rely on oral forms of olanzapine. TEV‑749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once‑monthly treatment," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva.
"For too long, the lack of a viable long‑acting olanzapine formulation has limited the options available to these individuals, and we look forward to working with the FDA on the review of this NDA for TEV‑749 to help address this gap in care," added Christophe Douat, CEO of Medincell.
The acceptance positions TEV‑749 as a key addition to Teva’s schizophrenia portfolio, strengthening its long‑acting injectable franchise and potentially improving patient adherence by removing the burden of post‑injection monitoring. No immediate market reaction was reported following the announcement.
The FDA’s acceptance is a significant regulatory milestone that could accelerate TEV‑749’s path to approval and broaden Teva’s competitive footprint in a market where adherence remains a major challenge for schizophrenia treatment.
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