Teva Receives Complete Response Letter For TV-46000/mdc-IRM For Schizophrenia Treatment

(RTTNews) - Teva Pharmaceuticals and MedinCell said Tuesday that the U.S. Food and Drug Administration has issued a Complete Response Letter or CRL regarding the New Drug Application or NDA for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.

The companies remain committed to the development of risperidone and to providing patients with access to the product in the U.S., as quickly as possible. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations, Teva said in a statement.