Posted by Michael Wonder on 08 Oct 2019
FDA accepts resubmitted new drug application for ITCA 650
8 October 2019 - Intarcia Therapeutics announced today that the U.S. FDA has accepted the company's resubmission of its new drug application for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus.
Intarcia resubmitted the NDA on 9 September 2019 and the FDA has recently communicated that it considers the resubmission a complete class 2 response, setting the Prescription Drug User Fee Act target action date of 9 March 2020.
