Tuesday, January 26, 2010

FDA announces new drugs and recall of certain needles

Over the past few days, the FDA has made some major announcements.

First, they announced a few new drugs:
  • Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults (Novo Nordisk). Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists that help the pancreas make more insulin after eating a meal.
  •  Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients (Roxane Laboratories). This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. This is the only FDA approved morphine sulfate oral solution available at this concentration.
The FDA also announced  the approval of a new cardiovascular medical device:
  • Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery. The FDA approved the Melody under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment or diagnosis of diseases or conditions affecting fewer than 4,000 people in the United States per year. Under an HDE, the FDA can approve a device for limited use if there is a reasonable assurance that the device is safe and if the probable benefit to health outweighs the risk of injury or illness. Such products can only be used at medical institutions with an overseeing Institutional Review Board.
Finally, the FDA announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. These needles should be designed to penetrate the port without cutting and dislodging any silicone cores (or slivers) from the ports into which they are inserted.

You can catch up with all these recent FDA updates by clicking here to read their latest press releases.

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