FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved an Acclarent de novo petition to permit marketing of the Aera Eustachian Tube Balloon Dilation System for treating persistent eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.

FDA has approved a Medtronic PMA for the IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease. This is the first drug-coated balloon approved to treat in-stent restenosis in the U.S.

Carl Zeiss Meditec has gained PMA approval for the VisuMax Femtosecond Laser for the small incision lenticule extraction procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older. The device removes a small amount of eye tissue to permanently reshape the cornea.

Obalon Therapeutics has won PMA approval for the Obalon Balloon System, a nonsurgical, reversible device for weight loss. The swallowable intragastric balloon device is indicated for temporary use to facilitate weight loss in adults with obesity who have failed to lose weight through diet and exercise

DRUGS

FDA has approved an Aralez Pharmaceuticals NDA resubmission for Yosprala (aspirin and omeprazole), indicated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

A Glenmark Pharmaceuticals ANDA has been granted final FDA approval for diclofenac sodium gel, 3%, the generic version of Fougera Pharmaceuticals’ Solaraze Gel, indicated for treating actinic keratoses, a precancerous skin growth usually caused by sun exposure.

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