FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared an Access Scientific 510(k) for its new 3 French, 6cm Powerwand, an extended-dwell intravenous (IV) catheter designed for forearm and upper-arm (midline) placement to eliminate the repetitive needlesticks experienced by many hospitalized patients. The device is made of proprietary Chronoflex C, and is longer than standard hospital IVs and more effective for drawing blood tests, administering fluids (75 ml/min) and power-injecting computed topography contrast media (8ml/sec), the company says.

DRUGS

FDA has approved Marathon Pharmaceuticals’ Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 and older with Duchenne muscular dystrophy (DMD). An agency news release says that Emflaza is a corticosteroid that works by decreasing inflammation and reducing immune system activity. Although corticosteroids are commonly used to treat DMD across the world, this is the first FDA approval of any corticosteroid to treat DMD and the first approval of deflazacort for any use in the U.S.

FDA has approved Bio Products Laboratory’s Gammaplex 10% (immune globulin intravenous [human], 10% liquid) for treating primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura in adults. Gammaplex 10% is made with the same process as the company’s previously approved Gammaplex 5%. The latest product, Bio Products says, is more concentrated than the previous product, with an immune globulin G concentration of 100g/L, and is stabilized with glycine.

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) injection, for intravenous use for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months after neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The indication was approved under accelerated approval based on tumor response rate and duration of response.

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