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Teva submits FDA application for monthly injectable schizophrenia treatment using Medincell's technology.
Teva Pharmaceuticals, with Medincell's technology, has submitted a New Drug Application to the FDA for TEV-‘749, a once-monthly injectable olanzapine treatment for adult schizophrenia.
The application, based on the phase 3 SOLARIS trial, uses SteadyTeq™ copolymer technology for sustained release.
It aims to improve adherence and stability by replacing daily pills with a monthly injection, addressing a major gap in schizophrenia care.
The FDA will review the application to determine approval.
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Teva presenta una solicitud a la FDA para el tratamiento mensual inyectable de la esquizofrenia usando la tecnología de Medincell.