FDA News Digest
'FDA Approves First Artificial Disc to Treat Common Cause of Neck, Arm Pain
FDA has approved the Prestige Cervical Disc, the first artificial cervical (neck)
disc for treating cervical degenerative disc disease, one of the most common causes of neck and arm pain. FDA based its approval on a clinical study of 541 patients showing that the device improved neck
or arm pain and was as safe and effective as the current treatment of cervical fusion.
EMMA' Cleared; Allows Remote Release of Prescription Drugs
FDA has cleared for marketing the Electronic Medication Management Assistant (EMMA), a device that
allows health professionals to remotely manage prescription medicine that is stored and released by a patient-operated delivery system. EMMA can help reduce drug identification and dosing errors, and it
provides a monitor for patient adherence to drug regimens.
New Drug Lyrica Helps Treat Some Patients With Fibromyalgia
FDA has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by
pain, fatigue, and sleep problems. The drug was shown in clinical trials to reduce pain and improve daily functions for some fibromyalgia patients.
Rule Finalized to Help Ensure Dietary Supplement Quality
FDA has issued a final rule establishing requirements to ensure that dietary supplements are produced in
a quality manner, do not contain contaminants or impurities, and are accurately labeled. The rule also includes requirements for recordkeeping and for handling consumer complaints. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html
Shelhigh Agrees to Stop Device Distribution Pending Problem Fixes
New Jersey implantable medical device company Shelhigh Inc. has agreed to stop distributing its
products until the company's production processes comply with FDA manufacturing and quality regulations. Among Shelhigh's products are pediatric heart valves, surgical patches, and arterial
FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension
FDA approved Letairis (ambrisentan) for the treatment of pulmonary arterial
hypertension, a rare, life-threatening condition characterized by continuous high blood pressure within the arteries of the lungs. Letairis was granted orphan drug status by FDA because it treats a rare
disease and meets other criteria. Orphan designation qualifies the drug's sponsor for a tax credit and marketing incentives. -- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01653.html
FDA Takes Steps to Reduce Tomato-Related Foodborne Illness
FDA is beginning a multi-year initiative designed to reduce tomato-related foodborne illness. Over the
last decade, fresh and fresh-cut tomatoes have been linked to 12 foodborne illness outbreaks, resulting in 1,840 confirmed cases of illness. The initiative is a collaboration between FDA, state officials
in Florida and Virginia, academia, and the produce industry. -- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01651.html
'Blitz' Finds No Widespread Problems in Human Tissue Recovery
FDA's Human Tissue Task Force has released a report concluding that there are no
significant industry-wide problems in the recovery of human tissues for transplantation. The agency conducted a "blitz" between October 2006 and March 2007, inspecting 153 tissue recovery
companies. Though FDA observed some deviations from regulations, the agency found no inaccuracies or deficiencies that could put tissue recipients at risk. -- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01650.html
Software Tool Aims to Keep Food Facilities Safe from Attack
FDA has released the CARVER + Shock Software Tool to help the food industry determine the
vulnerability of individual food facilities to biological, chemical or radiological attack. The U.S. military originally developed the tool to identify areas vulnerable to attack. FDA and the U.S.
Department of Agriculture adapted it for the food and agriculture sector. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01652.html
The week before...
FDA News Digest
Rx Weight-Loss Drug Orlistat Approved for OTC Sales
FDA has approved orlistat as an over-the-counter (OTC) weight-loss aid for overweight adults. FDA first approved the drug in
1999 as a prescription treatment for obesity. Orlistat still will be dispensed by prescription for obesity at a higher dose than the OTC version, which will be sold under the name Alli. Orlistat helps
produce weight loss by decreasing the intestinal absorption of fat.
Two Approved Uses to be Removed from Antibiotic Ketek
After considering the risks and benefits of the three approved uses of the antibiotic Ketek (telithromycin), FDA has
determined that two of those uses no longer support approval of the drug for those purposes. The two uses that will be dropped from the drug's labeling are acute bacterial sinusitis and acute
bacterial exacerbations of chronic bronchitis. However, Ketek will stay on the market for treatment of mild-to-moderate community-acquired pneumonia.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html
-- Ketek information page: http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm
Device Cleared to Help Save Limbs of Critically Injured
FDA has cleared the Temporary Limb Salvage Shunt, a medical device that can help save the arms and legs of critically injured
soldiers and other trauma victims. The device works by connecting the ends of a severed blood vessel, providing a bridge around the damaged area and restoring blood flow to the injured limb.
Two Firms to Stop Making Devices Pending Compliance
Two medical device companies have agreed to stop making certain products until problems with legal compliance are resolved.
California-based Cardinal Health 303 Inc. and three of its top executives have signed a consent decree in U.S. district court instructing them to correct manufacturing deficiencies before making and
distributing any more of the company's Signature Edition infusion pumps. Likewise, Custom Ultrasonics Inc. has agreed to stop marketing its System 83 Plus Washer/Disinfectors and its System Plus 83
Mini-flex Washer/Disinfectors until manufacturing problems are resolved.