Posted by Michael Wonder on 12 Dec 2017
Indivior announces NDA acceptance of RBP-7000 risperidone monthly depot
12 December 2017 - A novel sustained-release candidate for treatment of schizophrenia.
Indivior today announces that the U.S. FDA has accepted the new drug application for RBP-7000, an investigational, once-monthly injectable risperidone in the Atrigel delivery system for the treatment of schizophrenia.
The application, which was submitted on 28 September 2017, is based on data from the pivotal Phase 3 study assessing clinical efficacy and safety and from the long-term safety study of RBP-7000. The FDA has set a Prescription Drug User Fee Act target action date of 28 July 2018.
