Press releases from FDA http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml en-us Fri, 24 May 2013 13:33:00 -0400 tina.gilliam@fda.hhs.gov The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn. Fri, 24 May 2013 13:33:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed for this use. Thu, 23 May 2013 15:14:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353653.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353653.htm The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients. Sat, 18 May 2013 14:32:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352948.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352948.htm The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated. Fri, 17 May 2013 13:38:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352874.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352874.htm The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Wed, 15 May 2013 16:00:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352383.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352383.htm The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. Wed, 15 May 2013 10:28:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352363.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352363.htm On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule. Tue, 14 May 2013 15:09:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352280.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352280.htm The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC). Tue, 14 May 2013 15:33:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352230.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352230.htm The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities. Mon, 13 May 2013 14:49:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352093.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352093.htm The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled. Fri, 10 May 2013 11:59:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351754.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351754.htm The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. Fri, 10 May 2013 11:10:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection. Wed, 08 May 2013 13:34:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351254.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351254.htm Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices. Mon, 06 May 2013 14:38:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350864.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350864.htm The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics. Mon, 06 May 2013 13:20:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350866.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350866.htm The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older. Tue, 30 Apr 2013 17:16:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition. Tue, 30 Apr 2013 12:14:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350091.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350091.htm The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. Mon, 29 Apr 2013 17:56:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350026.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350026.htm The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3. Wed, 24 Apr 2013 13:00:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm349195.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm349195.htm Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls. Sun, 21 Apr 2013 10:35:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348787.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348787.htm The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting). Tue, 16 Apr 2013 16:30:00 -0400 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm348252.htm