Posted by Michael Wonder on 15 Mar 2020
For second time, FDA rejects Intarcia's diabetes implant
11 March 2020 - Boston-based Intarcia continues to run into a regulatory roadblock concerning its implanted diabetic pump ITCA 650. This week the U.S. FDA issued its second complete response letter for the device.
In September 2017 the FDA rejected ITCA 650 due to concerns regarding manufacturing issues. After addressing those concerns, Intarcia resubmitted its new drug application to the FDA in October and had a PDUFA date set for March 9.
In a statement issued to the Boston Business Journal, Intarcia expressed both disappointment and a determination to get an approval for ITCA 650.
