http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml en-us tina.gilliam@fda.hhs.gov The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat. Thu, 02 Jul 2009 14:39:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170276.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170276.htm The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs. Wed, 01 Jul 2009 16:17:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing. Tue, 30 Jun 2009 16:37:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169853.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169853.htm Today, the U.S. Food and Drug Administration announced that it has found E. coli O157:H7 (a bacterium that can cause serious food borne illness) in a sample of prepackaged Nestlé Toll House refrigerated cookie dough currently under recall by the manufacturer and marketer, Nestlé USA. The contaminated sample was collected at Nestlé’s facility in Danville, Va. on June 25, 2009. Tue, 30 Jun 2009 00:35:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169733.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169733.htm A registered nurse who directed an allergy testing health care fraud scheme, was sentenced to nine years in prison and ordered to pay $2.6 million in restitution, federal law enforcement officials announced today. John Froelich, 52, formerly of Harwood Heights, was the ringleader among nine defendants who pleaded guilty to federal charges for submitting fraudulent bills totaling $11.5 million to more than 200 insurance companies, which paid approximately $2.6 million in false claims. Mon, 29 Jun 2009 04:00:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169862.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169862.htm FDA, USDA, CDC investigating; no link to human illnesses at this time. Plainview Milk Products Cooperative, Plainview, Minn., is voluntarily recalling all instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two years, because they might be contaminated with Salmonella. Sun, 28 Jun 2009 19:46:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169471.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169471.htm Timothy Keay Isaac, 47, of Scottsdale, Ariz., pleaded guilty earlier this week to Conspiracy, Introducing Misbranded Drugs into Interstate Commerce, Making False Tax Returns, Filing False Declarations in a Bankruptcy Proceeding and Theft of Government Money. Fri, 26 Jun 2009 04:00:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169656.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169656.htm U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. Thu, 25 Jun 2009 18:01:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169093.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169093.htm The former managing pharmacist at a Middlesex County pharmacy pleaded guilty today to conspiring to defraud health insurers, including the federal Medicaid program, by submitting phony claims for reimbursement for prescription drugs, Acting U.S. Attorney Ralph J. Marra, Jr., announced. Wed, 24 Jun 2009 18:34:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169369.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm169369.htm The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under. Wed, 24 Jun 2009 16:47:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168870.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168870.htm The U.S. Food and Drug Administration will host a daylong meeting on June 24, 2009. During this meeting, the FDA will seek recommendations on how to make information on FDA activities and decision-making useful, understandable, and more accessible to the public. The meeting is scheduled for 8 a.m. to 5 p.m. EDT at the National Transportation Safety Board Conference Center, 429 L’Enfant Plaza, S.W., Washington, D.C., 20594. Tue, 23 Jun 2009 14:00:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168583.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168583.htm The U.S. Food and Drug Administration is warning consumers not to eat California Prime Produce and Orange County Orchards brands of pistachios repacked by Orca Distribution West Inc., Anaheim, Calif. Orca received and repacked pistachios recalled by Setton Pistachio of Terra Bella Inc., Terra Bella, Calif. Mon, 22 Jun 2009 23:46:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168574.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168574.htm A federal grand jury yesterday indicted Pamela Arrey, age 48, Glenelg, Maryland, for health care fraud and aggravated identity theft, announced United States Attorney for District of Maryland Rod R. Rosenstein Fri, 19 Jun 2009 18:36:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168084.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168084.htm The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning consumers not to eat any varieties of Nestle Toll House Refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Fri, 19 Jun 2009 13:20:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167908.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167908.htm BOSTON, MA - A Branchburg, NJ, woman was sentenced today for violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration. Thu, 18 Jun 2009 21:56:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167880.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167880.htm The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness. Tue, 16 Jun 2009 18:43:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167187.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167187.htm The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent. Tue, 16 Jun 2009 16:10:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm U.S. Attorney news release Tue, 16 Jun 2009 04:00:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167435.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167435.htm KANSAS CITY, Mo. – Matt J. Whitworth, Acting United States Attorney for the Western District of Missouri, announced that a Nevada company and its owners pleaded guilty in federal court today to distributing a tainted ingredient used to make pet food, which resulted in a nationwide recall of pet food and the death and serious illness of countless pets across the United States in 2007. Tue, 16 Jun 2009 04:00:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167410.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167410.htm The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus. Mon, 15 Jun 2009 18:52:00 UTC http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166801.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166801.htm