Press releases from FDA http://www.fda.gov en-us Fri, 08 May 2009 18:57:00 GMT tina.gilliam@fda.hhs.gov The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. Fri, 08 May 2009 18:57:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02014.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02014.html The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget. Thu, 07 May 2009 17:47:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02013.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02013.html At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized more than $1.5 million worth of food products, including herbs and botanicals, stored under filthy conditions at the American Mercantile Corporation of Memphis, Tenn. Thu, 07 May 2009 17:19:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02012.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02012.html The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1 percent and Testim 1 percent, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure). Thu, 07 May 2009 16:03:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency’s unapproved drugs initiative. Thu, 07 May 2009 14:40:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02010.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02010.html The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder. "Schizophrenia can be a devastating illness requiring lifelong treatment and therapy," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives." Wed, 06 May 2009 21:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02009.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02009.html The U.S. Food and Drug Administration (FDA) announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain. Wed, 06 May 2009 20:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02008.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02008.html The U.S. Food and Drug Administration and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus. The agencies are also advising operators of offending web sites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face enforcement action. Fri, 01 May 2009 18:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02007.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02007.html The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. Fri, 01 May 2009 15:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. Thu, 30 Apr 2009 23:16:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02005.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02005.html The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs. Tue, 28 Apr 2009 17:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Food and Drug Administration (FDA) today launched an initiative to help ensure the safe use of methadone. A prescription drug best known as a treatment for addiction and dependence on heroin and other narcotic pain medicines, methadone is also prescribed to treat moderate-to-severe chronic pain patients. The campaign responds to concerns about an escalating number of poisoning deaths linked to the improper use of this medication. Tue, 28 Apr 2009 14:49:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02003.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02003.html The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test. Mon, 27 Apr 2009 23:57:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02002.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02002.html The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time. Sun, 26 Apr 2009 22:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02001.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02001.html The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. Wed, 22 Apr 2009 20:44:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW02000.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW02000.html On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older. Wed, 22 Apr 2009 20:44:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01999.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01999.html An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus. Tue, 21 Apr 2009 20:55:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01998.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01998.html The U.S. Food and Drug Administration (FDA) is alerting the public to the expanded, voluntary recall by Union International Food Company (Union City, Calif.) of sauces, oils, and oil blends sold under the Uncle Chen and Lian How brands. Thu, 16 Apr 2009 21:40:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01997.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01997.html The U.S Food and Drug Administration today announced that Coast IRB, LLC of Colorado Springs, Colo., has agreed to voluntarily halt some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials. Tue, 14 Apr 2009 18:55:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01996.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01996.html The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs. Fri, 10 Apr 2009 16:25:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01995.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01995.html The U.S Food and Drug Administration today amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis. Thu, 09 Apr 2009 22:11:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01994.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01994.html The U.S. Food and Drug Administration today approved a new prescription medication for the treatment of head lice ( Pediculosis capitis ) infestation. Benzyl Alcohol Lotion, 5 Percent, received full market approval as a prescription medication, for use in patients 6 months of age and older. Thu, 09 Apr 2009 21:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01993.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01993.html Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States. Wed, 08 Apr 2009 21:02:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01992.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01992.html The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency's most stringent premarket review process. Wed, 08 Apr 2009 15:24:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01990.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01990.html