Due to a technical difficulty with our listserve software, you may not have received the February 17, 2004, issue of the FDA News Digest so we are resending it here. We apologize for any inconvenience.
FDA News Digest
February 17, 2004
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THIS WEEK'S NEWS
-- New Type of Drug Treatment for Advanced Colon Cancer Approved
-- Hormone Therapy Information for Postmenopausal Women Updated
-- FDA Acts Against Three More Sellers of Fake Contraceptive Patches
-- Testimony
-- Meetings
NEW TYPE OF DRUG TREATMENT FOR ADVANCED COLORECTAL CANCER APPROVED
FDA has approved Erbitux (cetuximab) to treat patients with advanced colorectal cancer that has spread to other parts of the body. Erbitux, a product of genetic engineering, is a new type of drug believed to work by targeting a protein on the surface of cancer cells, interfering with cell growth. Colorectal cancer is the third most common cancer affecting both men and women in this country, and is the second leading cause of cancer-related death. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01024.html
HORMONE THERAPY INFORMATION FOR POSTMENOPAUSAL WOMEN UPDATED
FDA is asking makers of hormone therapy products -- estrogen and estrogen/progestin combinations -- for use by postmenopausal women to include in their labeling recent data from the Women's Health Initiative Memory Study. The study found an increased risk of dementia in women 65 or older during four years of treatment with estrogen plus progestin. FDA emphasizes that although these findings are statistically significant, the risks to individual women are small. Press release (English): http://www.fda.gov/bbs/topics/NEWS/2004/NEW01022.html
Press release (Spanish): http://www.fda.gov/bbs/topics/NEWS/spanish/NEW01022.html
Estrogens information page: http://www.fda.gov/cder/drug/infopage/estrogens_progestins/default.htm
FDA ACTS AGAINST THREE MORE SELLERS OF FAKE CONTRACEPTIVE PATCHES
FDA has taken action against three foreign-based Web sites that sold counterfeit versions of Johnson & Johnson's Ortho Evra contraceptive patch. The fake patches contain no active ingredients and will not protect against pregnancy. The sites are usarxstore.com, europeanrxpharmacy.com, and generic.com. FDA has worked with the sites' U.S.-based Internet provider to shut down service to the sites. The move follows a similar FDA action taken earlier this month against rxpharmacy.ws, which also was selling fake patches. Press release: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01023.html
Photos of real and fake patches: http://www.fda.gov/bbs/topics/news/photos/contraceptive/counterfeit.html
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RECENT TESTIMONY
Robert J. Meyer, M.D., director, Office of Drug Evaluation II, FDA Center for Drug Evaluation and Research; before the House Committee on Government Reform; concerning prescription drug abuse (Feb. 9) http://www.fda.gov/ola/2004/oxycontin0209.html
For an archive of testimony by FDA officials, go to http://www.fda.gov/ola/listing.html
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PUBLIC MEETINGS
March 17 -- FDA/Drug Information Association Workshop: "Combating Counterfeit Drugs;" Washington, D.C. http://www.diahome.org/Content/Events/04027.pdf
For a list of other upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html.
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