FDA News Digest August 9, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- Two Fixed-Dose Combination Drugs Approved to Treat HIV -- Injectable Filler Sculptra Approved for HIV-Related Facial Wasting -- FDA's Acting Commissioner Sets Agency Priorities for Next 6 Months -- Recalls/Market Withdrawals -- Public Meetings -- Recent Speeches ______________________________________________________________ Two Fixed-Dose Combination Drugs Approved to Treat HIV FDA has approved Epzicom and Truvada, two fixed-dose combination treatments for HIV infection. Combination treatments bring together different HIV/AIDS drugs in a single medication to help make treatment less complicated by reducing the number of pills and times per day that patients need to take them. Both of the new drugs are intended for use with other HIV/AIDS drugs. http://www.fda.gov/bbs/topics/news/2004/NEW01099.html Injectable Filler Sculptra Approved for HIV-Related Facial Wasting Sculptra, an injectable filler, is the first product FDA has approved for treating the facial wasting that is common among HIV-infected patients. It has been shown to increase skin thickness, add volume to facial tissue, and restore shape to facial areas with fat loss. http://www.fda.gov/bbs/topics/news/2004/NEW02000.html FDA's Acting Commissioner Sets Agency Priorities for Next 6 Months Calling the next six months "a critical period," FDA Acting Commissioner Lester M. Crawford, D.V.M., unveiled a lengthy list of agency priorities Aug. 2 that he says will help "strengthen public health and build on [FDA's] accomplishments in the recent past." Priorities include: promoting faster access to new medical technologies; issuing manufacturing practice guidance for dietary supplement makers; helping make lower-cost medicines available to as many people as possible; and proposing a clarification of nutrient content claims related to the carbohydrate content of foods. http://www.fda.gov/bbs/topics/news/2004/NEW01098.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Minerva Patient Lifts; model numbers ML20 and ML30 (mechanical problems) http://www.fda.gov/oc/po/firmrecalls/medibo08_04.html Outta Hand Ceramic Porcelain Cocktail Plates (high lead levels) http://www.fda.gov/oc/po/firmrecalls/axis08_04.html Roxy Brand White Sesame Seeds (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/roxy08_04.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ PUBLIC MEETINGS Sept. 20-24 -- 2004 PDA/FDA Joint Regulatory Conference; Washington, D.C. http://www.pda.org/pdafda2004/index.html For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M, before the National Medical Association, House of Delegates Meeting, San Diego (Aug. 4) http://www.fda.gov/oc/speeches/2004/nma0804.html FDA Acting Commissioner Lester M. Crawford, D.V.M.; Newsmaker Luncheon, National Press Club, Washington, D.C. (Aug. 2) http://www.fda.gov/oc/speeches/2004/bascrty0707.html To view an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be August 16. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST
