Intarcia Appeals Advisory Committee On Diabetes Drug-Device Combo, Claiming ‘Misrepresentation’

 
• By Brenda Sandburg

Company contends US FDA gave the committee ‘materially false and misleading information’ about ITCA 650 exenatide implant and did not focus on GLP-1 comparative claims as it seeks a hearing before the commissioner following the panel’s unanimous vote against the application.

Appeal filing
Intarcia appeals the decision of FDA advisory committee that benefits of its diabetes treatment do not outweigh its risks. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers