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FDA Approvals-New Drugs, Diagnostics and Devices


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Bowel Function: FDA Approves Entereg to Help Restore Bowel Function Following Surgery

...approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01838.html

IBS-Irritable Bowel Syndrome: FDA Approves Amitiza for IBS-C

Only drug available in United States for irritable bowel syndrome with constipation
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01828.html

Coronary Artery Plaque Imaging Device Cleared by FDA

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01827.html

Constipation: FDA Approves Relistor for Opioid-Induced Constipation

Drug will help reduce effects of drugs like morphine on bowel function
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01826.html

Latex: FDA Clears Glove Made from New Type of Latex

...from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01822.html

Crohn's Disease: FDA Approves Cimzia to Treat Crohn's Disease

Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies...
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html

Heart Assist Device: FDA Approves First Compact Heart Assist Device

...novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01820.html

Gastroenteritis: FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

...approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01814.html

Burn Patients: FDA Approves New Medical Adhesive to Treat Burn Patients

The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01807.html

Proton pump inhibitors: FDA Approves Nexium for Use in Children Ages 1-11 Years

Nexium is part of a class of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of acid produced in the stomach and help heal erosions in the lining of the esophagus known as erosive esophagitis
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01802.html
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