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FDA News Briefs for Thursday, April 5, 2018

April 5, 2018

These Food and Drug Administration (FDA) developments came in this week:


FDA Expands Indications for Cardioform Septal Occluder

The FDA has approved a supplemental premarket approval (PMA) for the Cardioform Septal Occluder (W.L. Gore & Associates Inc.) for the closure of  patent foramen ovale in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. The Cardioform Septal Occluder is a permanently implanted device that is placed during a percutaneous, transcatheter procedure. The FDA previously approved the device for closure of ostium secundum atrial septal defects. More Information.


FDA Approves Efficacy Labeling Change for Bydureon

The FDA has approved a supplemental NDA for Bydureon (exenatide extended-release; AstraZeneca), an injectable therapy for type 2 diabetes (T2D). The approval provides for updates to the Bydureon label prescribing information to include efficacy data from the phase III DURATION 7 trial, which found that Bydureon versus placebo significantly improved glucose control when used as an add-on therapy to basal insulin in adults with T2D and inadequate glycemic control. More Information.