FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Spinal Resources 510(k) for its Swedge Pedicle Screw System. The device offers cobalt-chromium and titanium tulips, double lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws, and minimally invasive spinal surgery options, according to the company. Currently, it is cleared for a 5.5mm rod; 4.75mm and 5.0mm rods are pending clearance.

FDA has cleared an OmniLife Science 510(k) for its proprietary robotic tissue balancing device for use with the company’s OmniBotics robotic-assisted total knee replacement technology platform. The device is intended to provide surgeons with a quantitative tool to actively manage the soft tissue envelope with real-time feedback, according to the company.

FDA has cleared an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache. The prescription-only device uses single-pulse transcranial magnetic stimulation to induce a mild electric current that modulates nerve cells in the brain, according to the company.

DRUGS

FDA has approved Pfizer’s Mylotarg (gemtuzumab ozogamicin) for treating adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen (CD33-positive AML). Mylotarg was originally approved under FDA’s accelerated approval program in 2000 for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were age 60 or older. The drug was voluntarily withdrawn by Pfizer in 2010 after a confirmatory Phase 3 trial did not show a clinical benefit for its use as a single agent in patients with CD33-positive AML, and the rate of fatalities as a result of treatment-related toxicity was significantly higher in the Mylotarg arm of the trial.

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