FDA Policy/General

Product Approval Summaries

BIOLOGICS

Seqirus has received FDA approval of Afluria Quadrivalent (Influenza Vaccine) for use in persons 18 years of age and older. The company says it is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

DEVICES

FDA has cleared an Amedica 510(k) for expanded Valeo II Lateral Lumbar sizes for intervertebral body fusion of the spine in skeletally mature patients. The company says the interbody fusion device is composed of Amedica’s medical grade silicon nitride ceramic and its design consists of aggressive teeth for expulsion resistance, knurls for added stability, a threaded insertion feature for precision implant control, and two central cavities maximized for optimal bone graft packing.

Bio2 Medical has received FDA 510(k) clearance for the Angel Catheter, intended for use in preventing pulmonary embolism (PE) in patients who cannot take anticoagulation therapy. According to the company, the catheter is an alternative to inferior vena cava (IVC) filters for PE protection and is designed for bedside placement, without the need for fluoroscopic guidance. Bio2 also says it features a temporary IVC filter that is permanently attached to a central venous catheter, and has been shown to reduce the rates of PE-related morbidity and mortality by trapping clinically significant pulmonary emboli.

FDA has approved an ImPACT Applications’ de novo petition to allow the marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices approved that are intended to assess cognitive function after a possible concussion, according to an agency news release. The devices are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are designed to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. “The results are compared to an age-matched control database or to a patient’s pre-injury baseline scores, if available,” the agency says. ImPACT software runs on a desktop or laptop and is intended for those ages 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children ages five to 11.

HUMAN DRUGS

FDA has approved a Pfizer NDA for Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, indicated for treating pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. According to the company, the capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid antagonist.

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