Resubmissions Approvals – What it all means

This morning Intarcia announced that the FDA has accepted the resubmission of their exenatide micropump. Per a company issued press release;

“Intarcia Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its new drug application (NDA) for ITCA 650 (exenatide implant), for the treatment of type 2 diabetes mellitus. Intarcia resubmitted the NDA on September 9th, 2019 and the FDA has recently communicated that it considers the NDA resubmission a complete class 2 response, setting the Prescription Drug User Fee Act (PDUFA) target action date of March 9, 2020 . . .

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