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The first breath test for use in children ages 3 to 17 years to detect Helicobacter pylori (H. pylori) bacterial infections, responsible for chronic stomach inflammation (gastritis) and ulcers, was approved by the U.S. Food and Drug Administration (FDA). The FDA based its approval of the BreathTek UBT test for children on a multi-center study of 176 patients, comparing its performance to a composite reference method and demonstrating 95.8 percent sensitivity and 99.2 percent specificity. An additional study was done at 1 to 6 months after therapy to support use for post-treatment monitoring of patients. The sensitivity was 83.3 percent and the specificity was 100 percent.
Food and Drug Administration - Mon, 27 February 2012
http://www.fda.gov
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The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products including vaccines, blood and blood components, gene therapies, tissues, and proteins. Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials.
Food and Drug Administration - Tue, 14 February 2012
http://www.fda.gov
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The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. The labeling for the “homeopathic” HCG products states that each product should be taken in conjunction with a very low calorie diet. There is no substantial evidence HCG increases weight loss beyond that resulting from the recommended caloric restriction. Consumers on a very low calorie diet are at increased risk for side effects including gallstone formation, electrolyte imbalance, and heart arrhythmias. Human chorionic gonadotropin (HCG) is a hormone produced by the human placenta and found in the urine of pregnant women. HCG is FDA-approved as an injectable prescription drug for the treatment of some cases of female infertility and other medical conditions.
Food and Drug Administration - Tue, 13 December 2011
http://www.fda.gov
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The U.S. Food and Drug Administration issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.
Food and Drug Administration - Tue, 6 December 2011
http://www.fda.gov
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The U.S. Food and Drug Administration approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.
Food and Drug Administration - Mon, 28 November 2011
http://www.fda.gov
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The U.S. Food and Drug Administration allowed marketing of the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large aortic aneurysm, a bulge in the large blood vessel that carries blood away from the heart. FDA’s action will provide surgeons with a minimally-invasive option for repair of aortic endografts (endovascular grafts) that are not properly positioned.
Food and Drug Administration - Tue, 22 November 2011
http://www.fda.gov
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Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
Food and Drug Administration - Mon, 7 November 2011
http://www.fda.gov
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The U.S. Food and Drug Administration approved the first generic versions of olanzapine to treat schizophrenia and bipolar disorder. Generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs. The generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.
Food and Drug Administration - Tue, 25 October 2011
http://www.fda.gov
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The U.S. Food and Drug Administration today approved deferiprone to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
Food and Drug Administration - Wed, 19 October 2011
http://www.fda.gov
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This year’s IIWA, which ran between Sept. 20 and Sept. 27 is called OPERATION PANGEA IV, focused on websites supplying illegal and dangerous medicines. The operation is the largest Internet-based action of its kind in support of the International Medical Products Anti-Counterfeiting Taskforce. The goal of the IIWA is to protect the public health by increasing the public’s awareness about the dangers and risks associated with purchasing medicines and medical devices from websites, to identify the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, to target these individuals or businesses with civil or criminal action, and to seize counterfeit and illegal products and remove them from the supply chain.
Food and Drug Administration - Tue, 4 October 2011
http://www.fda.gov