Teva Pharmaceuticals has received notice from the U.S. Food and Drug Administration (FDA) that its application for a new drug, olanzapine extended-release injectable suspension (TEV-'749), has been accepted for review. This medication is designed for the once-monthly treatment of schizophrenia in adults. The acceptance marks a significant step in the process for potentially bringing a new therapeutic option to market for individuals living with this condition, aiming to improve long-term stability and treatment adherence.
Background on TEV-'749 and Schizophrenia Treatment
The drug application centers on TEV-'749, a new formulation of olanzapine intended for subcutaneous injection. This medication is a long-acting injectable (LAI) suspension, developed in collaboration with Medincell.
Schizophrenia is a complex mental health disorder that affects how a person thinks, feels, and behaves. The FDA's website offers general information on schizophrenia, noting its varied symptoms and the importance of ongoing treatment.
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The development of TEV-'749 is informed by the SOLARIS study, a large-scale, multinational trial. This study involved patients aged 18-64 diagnosed with schizophrenia.
Study Design: The SOLARIS study was randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers knew who received the active drug or a placebo. It was conducted across multiple research centers.
Study Phases:
Period One (8 weeks): 675 patients were randomly assigned to receive either a once-monthly injection of TEV-'749 (at low, medium, or high doses) or a placebo.
Period Two (48 weeks): Patients who completed the first period were then randomly assigned to one of the three TEV-'749 dosage groups.
Study Objectives:
Primary Objective: To measure how well TEV-'749 worked in adult patients with schizophrenia.
Secondary Objectives: To further examine the drug's effectiveness based on additional measures, and to assess its safety and how well patients tolerated it.
The FDA's acceptance of the New Drug Application (NDA) means the agency will now review the submitted data to determine if the drug is safe and effective for its intended use.
Key Stakeholders and Collaboration
The application was submitted by Teva Pharmaceutical Industries Ltd., a global pharmaceutical company with a focus on developing treatments for neurological conditions. Their "Pivot to Growth" strategy includes advancing innovative treatment options.
The development of TEV-'749 involved Medincell, a biotechnology company specializing in long-acting injectable drug delivery technologies.
The U.S. Food and Drug Administration (FDA) is the regulatory body responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. Their website, fda.gov, is a federal government site, identified by the .gov domain. The Federal Register, also mentioned, is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.
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Teva's Strategic Focus
Teva views TEV-'749 as a critical advancement in its portfolio, particularly within its long-acting injectable (LAI) franchise. The company aims for this drug to improve treatment adherence—ensuring patients consistently receive their medication—and to foster long-term stability for individuals with schizophrenia. This initiative aligns with Teva's broader strategy to address unmet needs in complex neurological and central nervous system conditions.
Comparison of NDA Acceptance Processes
The acceptance of Teva's NDA for TEV-'749 follows a similar regulatory pathway seen in other recent applications. For instance, Ono Pharmaceutical Co. Ltd. had its NDA for tirabrutinib, a treatment for a rare type of lymphoma, accepted by the FDA. This review is also proceeding under an accelerated pathway, with a decision date set for December 18, 2026.
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| Feature | Teva's TEV-'749 Application | Ono Pharmaceutical's Tirabrutinib Application |
|---|---|---|
| Drug Name | Olanzapine extended-release injectable suspension (TEV-'749) | Tirabrutinib |
| Company | Teva Pharmaceuticals, Medincell | Ono Pharmaceutical Co. Ltd. |
| Condition | Schizophrenia in adults | Relapsed or refractory PCNSL |
| Application Status | NDA Accepted for Review | NDA Accepted for Filing and Review |
| Development Basis | SOLARIS Phase 3 study | Phase 2 PROSPECT study, Phase 3 ongoing |
| Regulatory Pathway | Standard NDA review | Accelerated Approval Pathway |
| Prescription Drug User Fee Act (PDUFA) Date | Not specified in available data | December 18, 2026 |
Expert Commentary
The FDA's acceptance of Teva's NDA is a procedural milestone, indicating that the submitted application meets the basic requirements for a thorough scientific review. This process will involve evaluating all available data on TEV-'749's safety and efficacy. The focus on long-acting injectables like TEV-'749 is a trend in psychiatric care, aiming to improve patient outcomes by simplifying treatment regimens and potentially reducing relapse rates associated with inconsistent oral medication use.
Conclusion and Next Steps
The FDA's acceptance of Teva's NDA for olanzapine extended-release injectable suspension (TEV-'749) signifies the commencement of a formal review period. During this time, the FDA will meticulously examine the clinical trial data, manufacturing processes, and labeling information provided by Teva. The outcome of this review will determine whether TEV-'749 is approved for marketing in the United States as a treatment for schizophrenia. Further developments will be contingent on the FDA's scientific and regulatory assessment.
Sources
Stockwatch: U.S. Food and Drug Administration (FDA) Accepts Teva's New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the once-monthly treatment of schizophrenia in adults. (February 20, 2026).
URL: https://www.stockwatch.com/News/Item/U-z1001165934-U!TEVA-20260220/U/TEVA
U.S. Food and Drug Administration (FDA): Official government website.
URL: https://www.fda.gov/
Federal Register: Agency information for the Food and Drug Administration.
URL: https://www.federalregister.gov/agencies/food-and-drug-administration
Sahm Capital: FDA Accepts Ono Pharmaceutical's Tirabrutinib NDA for Review in Relapsed or Refractory PCNSL. (February 16, 2026).
URL: https://www.sahmcapital.com/news/content/fda-accepts-ono-pharmaceuticals-tirabrutinib-nda-for-review-in-relapsed-or-refractory-pcnsl-2026-02-16
Finviz: U.S. Food and Drug Administration (FDA) Accepts Teva's New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults. (Date not specified, Low Priority).
URL: https://finviz.com/news/317674/us-food-and-drug-administration-fda-accepts-tevas-new-drug-application-nda-for-olanzapine-extended-release-injectable-suspension-tev-749-for-the-once-monthly-treatment-of-schizophrenia-in-adults
USAGov: Food and Drug Administration (FDA) | Agencies. (Date not specified, Low Priority).
URL: https://www.usa.gov/agencies/food-and-drug-administration
