FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Myoscience 510(k) for its iovera device for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The device uses iovera’s technology and non-systemic treatment for blocking pain signals from peripheral nerves. It uses the “body’s natural response to cold to treat peripheral nerves,” the company says.

FDA has cleared a BrainCool AB 510(k) for the IQool System, intended for use for temperature reduction in adult patients when clinically indicated. The device is a “next-generation precision surface cooling system intended for temperature management with a focus on three independent anatomical zones: head/neck, thigh and torso,” according to the company.

FDA has cleared an Exactech 510(k) to market the ExactechGPS Shoulder Application that combines preoperative planning with computer-assisted shoulder arthroplasty surgery. The device is designed to help surgeons understand their patient’s anatomy prior to surgery, according to the company. “In addition, ExactechGPS provides a real-time view of retroversion and inclination, reaming and drilling depth, screw placement and the ability to adjust surgical plan intraoperatively, offering surgeons more flexibility,” it says.

DRUGS

FDA has approved two new indications for Merck’s Keytruda (pembrolizumab) for treating certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. One indication is for first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. The other indication is for second-line treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

FDA has approved the expanded use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. This more than triples the number of rare gene mutations that the drug can treat, from 10 mutations to 33. The agency based its decision, in part, on laboratory testing, which it used in conjunction with evidence from earlier human clinical trials.

FDA has approved an Abon Pharmaceuticals ANDA for clofarabine injection, 20 mg/20 mL, single-use vial, a generic copy of Genzyme’s Clolar injection, indicated for treating pediatric patients one year of age and older with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.

Gupta Raises Concerns About Overton’s Independence, Ideology

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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