FDA News Digest December 23, 2002 __________________________________________________________________ Gleevec Now Approved as First-Line Treatment of Chronic Myeloid Leukemia FDA has approved Gleevec (imatinib mesylate) as a first-line treatment for chronic myeloid leukemia (CML), a life-threatening form of cancer that affects about 40,000 people in the United States. Shown in clinical trials to slow disease progression better than standard therapy, Gleevec was first approved in 2001 to treat advanced stages of CML and also as a second-line treatment when other therapy failed. The new approval now gives patients access to the drug at an earlier stage in the disease. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00860.html __________________________________________________________________ Initiative to Improve Consumer Information for Foods, Dietary Supplements FDA has announced the Consumer Health Information for Better Nutrition initiative, which is designed to encourage makers of foods and dietary supplements to make science-based health claims about their products. The initiative also aims to help eliminate false or misleading claims related to dietary supplements. FDA also has released a report explaining its enforcement strategy to curb bogus labeling claims. Press release: http://www.fda.gov/bbs/topics/NEWS/2002/NEW00859.html Text of initiative: http://www.fda.gov/oc/nutritioninitiative/whitepaper.html Enforcement strategy report: http://www.fda.gov/oc/nutritioninitiative/report.html ___________________________________________________________________ OTC Glycated Hemoglobin Test Gives Diabetics New Tool to Manage Disease FDA has cleared for marketing the Metrika A1c Now, an over-the-counter (OTC) test to help diabetics monitor blood sugar levels. Formerly available only by prescription, the test's new OTC status means it will be readily available for use at home. The test, which measures glycated hemoglobin, is performed two to four times a year. By monitoring long-term control over blood glucose levels, it complements the short-term information from daily finger stick blood glucose tests. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01182.html ___________________________________________________________________ Clozaril OK'd for New Use: To Reduce Suicidal Behavior in Schizophrenics FDA has approved the drug Clozaril to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder. Initially approved in 1989 to treat schizophrenia patients nonresponsive to other treatments, the drug now is recommended for those at risk of reexperiencing suicidal behavior, based on a history of attempted suicide, hospitalization, or thoughts of suicide, with or without hallucinations. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01184.html ___________________________________________________________________ Safety Guidance Issued for Using Raw Meat in Diets of Pets and Zoo Animals Prompted by an increased use of raw meat for pets and zoo animals, FDA has issued a draft guidance for industry on the manufacture and labeling of diets containing raw meat, or other raw animal tissue, for consumption by these animals. The guidance includes warnings about bacterial contamination and dental or gastrointestinal trauma, and it recommends measures to minimize contamination and disease transmission. http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01183.html ___________________________________________________________________ Goodman Named Director of FDA Biologics Center Jesse Goodman, M.D., has been appointed director of the FDA Center for Biologics Evaluation and Research, taking over from Kathryn Zoon, Ph.D., who has accepted a job at the National Cancer Institute. Goodman, who has worked at FDA since 1998, has been active in public health issues such as human research subject protection and blood and vaccine safety. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00858.html ___________________________________________________________________ Note to Subscribers: FDA News Digest is taking a break the week of Dec. 30. We wish all of our subscribers happy holidays, and we'll return to your e-mailbox on Jan. 6. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
