FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared a Delta Med 510(k) for the DeltaVen Closed System Catheter. The peripheral intravenous device has a needle, extension tubing, and an option for a needleless connecter to the catheter. It will be available in a variety of sizes and configurations, including the only 26 gauge safety catheter in the U.S. market, the company says. The device will be distributed by Smiths Medical.

FDA has cleared an Orthofix International 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charcot foot, a debilitating condition where the bones in the foot weaken and collapse. The device is designed to be implanted in the medial and lateral columns of the foot to provide alignment, stabilization and fixation.

DRUGS

FDA has approved a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes study.

FDA has approved an expanded indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).

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