FDA News Digest June 23, 2003 ______________________________________________________________ First Nasal Mist Flu Vaccine Receives FDA Approval FDA has approved FluMist, the first nasally delivered influenza vaccine to be marketed in the United States. Also the first live-virus flu vaccine to be approved, FluMist is not intended for patients younger than 5 or older than 49. FDA says the new vaccine offers an option for eligible people reluctant to get a shot, and it should free up more of the injected flu vaccine for those at greatest risk and not approved for receiving FluMist. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00913.html ______________________________________________________________ FDA Approves Heartburn Drug Prilosec for Over-the-Counter Sales FDA has approved Prilosec OTC as the first over-the-counter treatment for frequent heartburn. FDA Commissioner Mark B. McClellan, M.D., says the switch of the drug from prescription to OTC status "will help reduce costs and expand the availability of treatment options for millions of Americans." Prilosec OTC is not intended for people who have heartburn infrequently (one episode a week or less) or for those who want immediate relief of heartburn. http://www.fda.gov/bbs/topics/news/2003/NEW00916.html ______________________________________________________________ Drug Company Receives Massive Penalties for Fraudulent Pricing Scheme AstraZeneca Pharmaceuticals LP has agreed to pay $355 million as part of criminal charges and civil liabilities in a scheme involving illegal pricing and marketing of the prostate cancer drug Zoladex. FDA's Office of Criminal Investigations worked closely on the investigation with the U.S. Attorney's Office, the Department of Health and Human Services, and the Defense Criminal Investigative Service. http://www.fda.gov/bbs/topics/news/2003/NEW00915.html ______________________________________________________________ First Biological Drug for Allergy-Related Asthma Approved FDA has approved Xolair (omalizumab), the first biological drug for people age 12 or older with moderate-to-severe allergy-related asthma inadequately controlled with inhaled steroid treatments. Asthma affects about 17 million Americans, and a small percentage of these will likely be appropriate candidates for the new drug. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01236.html ______________________________________________________________ Once-Daily Protease Inhibitor Approved for Treating HIV Infection FDA has approved Reyataz (atazanavir sulfate), a protease inhibitor intended for use in combination with other anti-retroviral drugs to treat HIV infection. The drug only needs to be taken once a day and joins six other approved protease inhibitors, which work at the final stages of viral replication to help prevent HIV from making new copies of itself. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01233.html ______________________________________________________________ FDA Recommends Antidepressant Paxil Not be Used in Those Under 18 Following reports of increased risk of suicidal thinking and attempts in children and adolescents treated for major depressive disorder (MDD) with the antidepressant Paxil, FDA is recommending that the drug not be used to treat MDD in these patients. However, the agency emphasizes that caretakers of pediatric patients already receiving Paxil for MDD should talk to their doctor before stopping use of the drug and that they should not discontinue it abruptly. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01230.html ______________________________________________________________ FDA Warns Consumers About Products Made by NVE Inc. FDA is warning consumers not to buy or use SIGRA, STAMINA Rx, STAMINA Rx for Women, Y-Y, Spontane ES, and Uroprin -- all marketed as dietary supplements but containing a prescription drug ingredient that poses possible health risks. The products are being sold over the counter with claims to increase stamina, confidence and performance. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01235.html ______________________________________________________________ Three Executives Indicted for Unsanitary Food Storage Following an inspection by FDA and the U.S. Department of Agriculture, three executives of Chicago-based LaGrou Distribution System Inc. have been indicted in federal court on charges of storing food in unsanitary, rodent-infested conditions. Food products involved in the case include meat, poultry, fish, nuts, butter, and milk fat -- all seized by federal officials. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01234.html ______________________________________________________________ FDA Investigation into Counterfeit Lipitor Prompts New Recalls Prompted by FDA's ongoing investigation into counterfeit Lipitor, two wholesale companies, Albers Medical Distributors Inc. and H.D. Smith Wholesale Drug Co., are recalling all Lipitor products repacked by Med-Pro Inc. Albers had recalled several lots of the counterfeit drug in recent weeks, but expanded the recall as a precautionary measure. Lipitor (atorvastatin calcium) is a prescription drug that, combined with diet, is used to lower blood cholesterol levels. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01229.html ______________________________________________________________ Pediatric Doses of Atropen OK'd for Treating Nerve Agent Exposure FDA has approved the Atropen (atropine autoinjector) for use in children and adolescents exposed to certain nerve agents or insecticides. Approved for adults since 1973, the Atropen should only be administered by people adequately trained in recognizing and treating nerve agent or insecticide poisoning. FDA has placed a high priority on making available safe and effective treatments such as the Atropen to help counter potential terrorist actions. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01232.html ______________________________________________________________ FDA, FTC Take Action Against Bogus 'Seasilver' Supplement FDA and the Federal Trade Commission are acting jointly against two companies charged with promoting the dietary supplement "Seasilver," falsely touted by the companies as a safe and effective treatment or cure for 650 diseases, including AIDS and cancers. FDA has seized inventories of the product. http://www.ftc.gov/opa/2003/06/seasilver.htm ______________________________________________________________ FDA Drugs/Biologics Consolidation Proceeding on Schedule FDA Commissioner Mark B. McClellan, M.D., says the merger of the agency's drug center with certain biologic product review functions is on track to be completed by June 30. The consolidation is expected to produce a more efficient, effective and consistent review function for human drugs and biologics. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01231.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information: Harris Teeter 6-Oz. Chopped Pecans (undeclared walnuts) http://www.fda.gov/oc/po/firmrecalls/harristeeter06_03.html Productos Real "Real Guacamole" (possible Listeria monocytogenes contamination) http://www.fda.gov/oc/po/firmrecalls/productos06_03.html ______________________________________________________________ RECENT TESTIMONY FDA Deputy Commissioner Lester M. Crawford, D.V.M., before the House Subcommittee on Conservation, Credit, Rural Development, and Research (June 17) http://www.fda.gov/ola/2003/biotech0617.html FDA Chief Counsel Daniel Troy, before the Senate Committee on the Judiciary (June 17) http://www.fda.gov/ola/2003/generic0617.html FDA Associate Commissioner William K. Hubbard, before the House Subcommittee on Human Rights and Wellness (June 12) http://www.fda.gov/ola/2003/canadian0612.html ______________________________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be June 30. 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
