19 April 2022 - Teva Pharmaceuticals and MedinCell announced that the U.S. FDA has issued a complete response letter regarding the new drug application for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.
Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations.