FTC Fines Diet Pill Makers Millions for Bogus Claims
January 4th 2007WASHINGTON -- The Federal Trade Commission announced today that it fined four makers of over-the-counter weight-loss products more than million for false advertising, including a .2 million civil penalty against Bayer for claims made for One-A-Day Weight Smart.
FDA Approves Head-Cooling Device to Treat Newborn Brain Disorder
December 20th 2006ROCKVILLE, Md. -- The FDA today approved Olympic Cool-Cap, a device that cools the head to prevent damage caused by neonatal hypoxic-ischemic encephalopathy (HIE), a condition that affects 5,000 to 9,000 newborns each year.
Ketek Antibiotic: Second-Line Therapy for Community-Acquired Pneumonia
December 15th 2006ROCKVILLE, Md. -- Two FDA advisory committees agreed today that the antibiotic Ketek (telithromycin) should be limited to second-line therapy for community-acquired pneumonia, and that the drug should have black box warning added to its label.
FDA Advisers Recommend Limits for Ketek Antibiotic
December 15th 2006ROCKVILLE, Md. -- Two FDA advisory committees agreed today that the antibiotic Ketek (telithromycin) should be limited to second-line therapy for community-acquired pneumonia, and that the drug should have black box warning added to its label.
FDA Adds Warning About Renal Risk to Trasylol Label
December 15th 2006ROCKVILLE, Md. -- The FDA announced today it had narrowed the indications for Trasylol (aprotinin injection), a drug used control bleeding during heart surgery, partly because of belatedly revealed risks of death or serious kidney damage.
Mortality in Phase III Trial Pulls Plug on HDL-Booster
December 4th 2006CLEVELAND -- The abrupt halt to clinical trials of torcetrapib, an investigational HDL-boosting agent, raises questions about any drug that inhibit cholesteryl ester transfer protein (CETP), according to cardiologist Steven Nissen, M.D., of the Cleveland Clinic.
FDA Adds Five New Indications and One Precaution to Gleevec
October 20th 2006ROCKVILLE, Md. -- The FDA has approved five new indications for Gleevec (imatinib mesylate), a tyrosine kinase inhibitor, all rare life-threatening disorders. At the same time the FDA added a precaution to Gleevec's label about congestive heart failure.
Novartis to Add Congestive Heart Failure to Gleevec Precautions
October 3rd 2006FLORHAM PARK, N.J. -- Novartis Oncology said today it would send letters to U.S. physicians this week advising them of a possible link between Gleevec (imitinib mesylate), the tyrosine kinase inhibitor, and congestive heart failure.