FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a CeloNova Biosciences PMA for its COBRA PzF NanoCoated Coronary Stent System. The device, which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to the company. The stent is designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease, including diabetics, due to de novo lesions in native coronary arteries with reference vessel diameter of 2.5 mm to 4 mm and lesion length 24 mm or less, it says.

FDA has approved a Medtronic PMA for the CoreValve Evolut PRO valve for treating severe aortic stenosis for symptomatic patients who are at high or extreme risk for open heart surgery. The approval was based on 30-day clinical data that “showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics for the self-expanding valve,” according to the company. The device is designed with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance, Medtronic says.

FDA has approved Alcon’s new AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ActiveFocus design for uncompromised distance vision and presbyopia correction. The device is intended to give astigmatic cataract patients “quality distance vision and an increased range of vision to potentially reduce dependence on glasses,” the company says.

DRUGS

FDA has approved a Shionogi Inc. and Purdue Pharma NDA for Symproic (naldemedine) 0.2 mg tablets, a once-daily oral peripherally-acting mu-opioid receptor antagonist for treating opioid-induced constipation in adult patients with chronic non-cancer pain. The companies say Symproic is currently a Schedule II controlled substance because it is “structurally related to naltrexone.”

FDA has approved a Newron Pharmaceuticals NDA for Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s therapy is not working well, and thus causing an increase in Parkinson’s symptoms, such as tremor and difficulty walking. Approval was based on data from a clinical trial involving 645 participants who were also taking levodopa and were experiencing “off” time.

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