FDA News Digest May 5, 2003 ______________________________________________________________ New Drug Treats Most Common Type of Lung Cancer FDA has approved Iressa (gefitinib) tablets for treatment of advanced non-small cell lung cancer, the most common form of lung cancer in the United States. Iressa is intended for patients whose cancer has progressed despite treatment with other chemotherapy drugs. FDA approved Iressa under a program that allows accelerated approvals of therapies for patients with serious diseases. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00901.html Iressa information page: http://www.fda.gov/cder/drug/infopage/iressa/default.htm _______________________________________________________________ New Test Monitors Asthma by Measuring Nitric Oxide in Breath FDA has cleared for marketing a first-of-a-kind test that should help doctors monitor a patient's response to anti-inflammatory asthma treatment by measuring the concentration of nitric oxide in the patient's breath. A decrease in exhaled nitric oxide suggests that treatment may be reducing the lung inflammation associated with asthma. The disease affects about 15 million Americans. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01219.html ______________________________________________________________ First Product Approved for Treating Rare Enzyme Deficiency FDA has approved Aldurazyme, the first treatment for patients with certain forms of a rare genetic disease called MPS1, which includes Hurler Syndrome. The disease results from the absence or malfunctioning of an enzyme that breaks down certain molecules in the cells. The buildup of these molecules results in cellular damage that affects appearance, physical abilities, organ functions and, in some cases, mental development. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01218.html ______________________________________________________________ FDA, Tech Firm Join Forces to Evaluate Adverse Event Data FDA has signed an agreement with Lincoln Technologies Inc., to use "data mining" techniques to evaluate data that FDA collects about adverse events involving approved drugs, biological products and vaccines. Through the partnership, FDA aims to identify patterns of adverse events, allowing the agency to take quick action to prevent future occurrences. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00899.html ______________________________________________________________ FDA, Hispanic Health Group Announce Improved Information Access FDA has joined with the National Alliance for Hispanic Health to help improve access to health information for Hispanic communities across the United States. Program goals include delivering information through a new toll-free help line and enhancing dialogue between the agency and Hispanic leaders on key health issues. Press release (Spanish): http://www.fda.gov/bbs/topics/NEWS/spanish/span00900.html Press release (English): http://www.fda.gov/bbs/topics/NEWS/2003/NEW00900.html ______________________________________________________________ False Health Claims Prompt Destruction of 'Nature's Youth' Supplements Massachusetts-based Nature's Youth LLC, has voluntarily destroyed $515,000 worth of its Nature's Youth hGH after FDA determined the company made false and misleading claims about the product on its website and in labeling. These claims included an unsubstantiated statement that Nature's Youth hGH enhances "the body's natural production of Human Growth Factors and Insulin-like Growth Factor-1." http://www.fda.gov/bbs/topics/NEWS/2003/NEW00898.html ______________________________________________________________ RECALLS The following products have been recalled for the reasons shown. Go to the linked page for more information: White Wave Vanilla Silk Soymilk (contaminant) http://www.fda.gov/oc/po/firmrecalls/whitewave2_04_03.html Peregrina Cheese Corp. Queso Fresco, Fresh Cheese (Listeria contamination) http://www.fda.gov/oc/po/firmrecalls/peregrina_state04_03.html Cosmeceutical Creations Corp. Leslie Dee Ann Jet Black Mascara (bacterial contamination) http://www.fda.gov/oc/po/firmrecalls/cosmeceutical04_03.html Forever Cheese Inc. Mitica Apricot Bars (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/forevercheese04_03.html ______________________________________________________________ PUBLIC MEETINGS May 7 Public Meeting, Satellite Broadcast to Discuss Bioterrorism Act FDA will sponsor a public meeting May 7 to discuss two sections of the Bioterrorism Act of 2002 regarding establishment and maintenance of records for foods and administrative detention of foods. The meeting will be broadcast by satellite to locations across the country, including sites in California, Florida, Massachusetts, and Ohio. http://www.fda.gov/CDRH/OHIP/DCM/html/cfsan_bio_2_event_page.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. _______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be May 12. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
