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New Pharmacokinetic Modeling Data Presented by Teva Simulates Clinical Profiles of Schizophrenia Patients Switching to UZEDY® (risperidone) Extended-Release Injectable Suspension at SIRS 2024
4/6/2024
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced the presentation of eight studies from its LAI schizophrenia research program, including data evaluating UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults.
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UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolongs Time to Schizophrenia Relapse in RISE Study Results Published in The Lancet Psychiatry
11/1/2023
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced the publication of efficacy and safety findings from the phase 3 Risperidone Subcutaneous Extended-Release study in The Lancet Psychiatry.
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Teva to Present Data for AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023
9/6/2023
Teva to Present Data for AUSTEDO ® XR (deutetrabenazine) Extended-Release Tablets, AUSTEDO ® (deutetrabenazine) Tablets and UZEDY™ (risperidone) Extended-Release Injectable Suspension at Psych Congress 2023.
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Teva Presents Real-World Data for AUSTEDO® (deutetrabenazine) Tablets with 4-Week Patient Titration Kit at Psych Congress Elevate 2023
6/2/2023
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced 12 presentations across its neuroscience portfolio featured at the Psych Congress Elevate 2023 Annual Meeting taking place on June 1-4, 2023.
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Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting
5/20/2023
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that four studies across its neuroscience portfolio will be presented during the American Psychiatric Association’s 2023 Annual Meeting taking place on May 20-24, 2023.
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Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults
4/29/2023
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell announced that the U.S. Food and Drug Administration has approved UZEDY extended-release injectable suspension for the treatment of schizophrenia in adults.
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Teva to Present Latest Research From Neurology Portfolio at the 2022 American Psychiatric Association Annual Meeting
5/17/2022
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced four data presentations for AUSTEDO® (deutetrabenazine) tablets and TV-46000/mdc-IRM.
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The FDA has issued a Complete Response Letter (CRL) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) to Teva Pharmaceuticals and MedinCell.
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MedinCell provides additional information regarding the new drug application for MDC-IRM
4/19/2022
As announced, Teva recently received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM.
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Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM
4/19/2022
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell announced that the U.S. Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for TV-46000/mdc-IRM for the treatment of schizophrenia.
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Researchers found that those who took either the once-a-month or once-every-two-month doses experienced longer periods before relapsing.
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Phase 3 Data of mdc-IRM, First Product Based On MedinCell’s Technology, Shows Significant Improvements in Patients With Schizophrenia:
11/1/2021
Developed in collaboration with Teva Pharmaceuticals, mdc-IRM, a risperidone extended-release injectable suspension for the treatment of patients with schizophrenia
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New Phase 3 Data Presented at Psych Congress 2021 Showed TV-46000/mdc-IRM Significantly Prolonged Time to Impending Relapse Compared to Placebo in Patients with Schizophrenia
10/30/2021
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release study comparing TV-46000/mdc-IRM once monthly and TV-46000/mdc-IRM once every two months with placebo in patients with schizophrenia who underwent stabilization on oral risperidone.
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Teva to Present New Data from Growing Mental Health Portfolio at Psych Congress 2021
10/21/2021
Teva Pharmaceuticals today announced 25 presentations examining new Phase 3 clinical data, post hoc analyses and open-label extension (OLE) studies for both TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) and AUSTEDO® (deutetrabenazine) tablets.
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Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia
8/31/2021
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell announced that the New Drug Application for TV-46000/mdc-IRM for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration.
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Teva and MedinCell Announce Positive Results for Registration Trial of Investigational Extended-Release Subcutaneous Injectable Risperidone for Patients with Schizophrenia
1/7/2021
Teva Pharmaceuticals Industries Ltd. (NYSE and TASE: TEVA) and MedinCell (Euronext: MEDCL) today announced positive results for study TV46000-CNS-30072 (the RISE study – The Risperidone Subcutaneous Extended-Release Study), a Phase 3 clinical trial designed to evaluate the efficacy of TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) as a treatment for patients with schizophrenia.