FDA Accepts Teva’s Application for Once-Monthly Olanzapine Injectable for Schizophrenia
The U.S. Food and Drug Administration (FDA) has accepted Teva Pharmaceutical Industries Ltd.’s New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-‘749) as a once-monthly treatment for schizophrenia in adults. The application is supported by data indicating a comparable efficacy and safety profile to existing olanzapine formulations, with the potential to improve patient adherence.
Key Features of TEV-‘749
TEV-‘749 is designed to be administered as a subcutaneous injection once a month. Unlike some current long-acting olanzapine formulations, it does not require a 3-hour post-injection monitoring period. This feature aims to reduce the burden on both patients and healthcare facilities. The treatment utilizes Medincell’s SteadyTeq™ copolymer technology, which provides a controlled and sustained release of olanzapine 1.
Addressing Adherence Challenges in Schizophrenia
“Treatment adherence remains a major challenge and unmet need for people living with schizophrenia,” said Eric Hughes, Chief Medical Officer at Teva. Improving adherence is a key goal of this new formulation.
Clinical Trial Data
The NDA is based on data from a late-stage clinical trial demonstrating that TEV-‘749, when administered monthly, showed an efficacy and safety profile consistent with currently available olanzapine formulations 3. The trial also indicated no need for post-injection monitoring.
About Schizophrenia
Schizophrenia is a chronic mental disorder that affects a person’s ability to believe, sense and behave clearly. Symptoms can include delusions, hallucinations, disorganized speech, and impaired cognitive function. Approximately 1% of the global population will develop schizophrenia during their lifetime 3.
Recent Developments for Teva
This FDA acceptance follows a recent ruling by the United States Court of Appeals for the Federal Circuit, which backed Teva in a patent dispute concerning Corcept Therapeutics’ Korlym tablets 4.
Stock Market Reaction
As of today, February 20, 2026, shares of TEVA were trading marginally lower 3. The stock has more than doubled in value over the past 12 months.
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