FDA Policy/General

Product Approval Summaries

BIOLOGICS

FDA has approved Ipsen Biopharmaceuticals’ sBLA for Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. The company says Dysport is the first FDA-approved botulinum toxin for treating the condition.

DEVICES

FDA has cleared an EndoChoice Holdings 510(k) for the Lumos with Adaptive Matrix Imaging, a proprietary imaging software system that is part of the company’s Generation 3 Fuse Full Spectrum Endoscopy System. The software is intended to analyze and selectively enhance the vascularity, surface texture, and color of abnormal tissue to assist physicians when detecting abnormalities during gastrointestinal procedures.

Luminex has received FDA 510(k) clearance for the Aries Flu A/B & RSV Assay. The test delivers results in less than two hours for detecting and differentiating three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus. The company says the assay also allows for “panel customization” with the ability to only report results of interest, and it “requires very limited hands-on time that accelerates the time to result and provides for increased accuracy.” It uses internal barcode scanning to minimize operator errors and features an integrated touchscreen computer to reduce “bench space” in lab settings, Luminex says.

Medical Compression Systems has obtained FDA clearance for its new comprehensive monitoring application, in combination with the ActiveCare online platform equipped with Bluetooth, which enables wireless data transmission between patients and their healthcare providers

FDA has approved Shire plc’s Baxject III reconstitution system for ADYnovate [Antihemophilic Factor, (Recombinant), PEGylated]. According to the company, the new system reduces the number of steps in the reconstitution process for hemophilia A patients and caregivers. Adynovate and the diluent will be pre-packaged in the Baxject III reconstitution system.

FDA has approved a W.L. Gore & Associates PMA for the Gore Tigris Vascular Stent, a dual-component stent with a fluoropolymer/nitinol design. The device was designed to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease, the company says. “The stent has been designed to weather biomechanical forces (extension, compression, flexion and torsion) without fractures, even in the most complex anatomies, namely in the superficial femoral artery and proximal popliteal artery,” the company says.

HUMAN DRUGS

GSK Consumer Healthcare has received FDA approval of its Flonase Sensimist Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter treatment for symptoms associated with seasonal and perennial allergies. It was previously available by prescription as Veramyst. The company says it helps block six allergic substances, providing non-drowsy, 24-hour relief of both nose- and eye-related allergy symptoms like itchy, watery eyes, nasal congestion, runny nose, itchy nose and sneezing.

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