FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent ischemic strokes. The device was previously approved for closure of atrial septal defects up to 17 mm. The expanded was supported by data from the REDUCE study, which was published in the New England Journal of Medicine 9/2017.

FDA has approved an expanded indication for Cardiva Medical’s Vascade vascular closure system for use in 5-7F femoral venous closures as well as for arterial closure. The company says the expanded indication “creates an opportunity to better treat patients undergoing interventional cardiac catheterization procedures, while also greatly increasing the available market for Vascade.”

DRUGS

FDA has approved an AstraZeneca NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with Type 2 diabetes with inadequate glycemic control. The expanded use is based on data from the 28-week DURATION-7 study, which examined the effect of Bydureon or placebo as add-on therapy to insulin glargine, with or without metformin.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome