USPharmacisthttp://www.uspharmacist.comhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/16506/11/19/2009 9:00:00 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/16506/http://www.uspharmacist.com/content/d/fda_fast_facts/c/16505/11/19/2009 9:00:00 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/16505/http://www.uspharmacist.com/content/d/fda_fast_facts/c/16507/11/19/2009 9:00:00 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/16507/http://www.uspharmacist.com/content/d/fda_fast_facts/c/12650/3/18/2009 9:00:00 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/12650/http://www.uspharmacist.com/content/d/fda_fast_facts/c/12649/3/18/2009 9:00:00 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/12649/http://www.uspharmacist.com/content/d/fda_fast_facts/c/12651/3/18/2009 9:00:00 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/12651/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11031/The FDA has broadened the indications for methylphenidate (Concerta) extended-release tablets in doses of 18 mg to 72 mg/day to include adults with attention-deficit hyperactivity disorder (ADHD).8/19/2008 11:27:30 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11031/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11033/The FDA added a boxed warning to the label of Regranex Gel 0.01% (becaplermin)--a topical cream for treating stubborn leg and foot ulcers in diabetic patients--due to increased risk of death from cancer.8/19/2008 11:27:30 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11033/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11032/The FDA has acted to require manufacturers of an older class of drugs known as conventional antipsychotics to add boxed warnings to their labeling about an increased risk of death associated with their off-label use to treat behavioral problems in older patients with dementia.8/19/2008 11:27:30 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11032/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10960/Following positive tests for Burkholderia cepacia, Sage Products has announced a voluntary recall of limited lots of its 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product.8/19/2008 11:24:30 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10960/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10920/United States marshals seized more than $1.3 million worth of dietary supplements from LG Sciences, LLC, of Brighton, Michigan, because the products contain unapproved food additives and/or new dietary ingredients.5/20/2008 8:04:57 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10920/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10918/The FDA has issued draft guidelines to aid the development, testing, and manufacture of coronary drug-eluting stents, devices for treating blocked heart arteries...5/20/2008 8:04:57 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10918/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10921/The FDA has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending approval from the Chinese government.5/20/2008 8:04:57 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10921/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10919/The FDA has identified 25 drugs and biologic products that will be required to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) safety plan by September 21, 2008.5/20/2008 8:04:57 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10919/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10922/The FDA issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous adverse event reports, including death, associated with the misuse and inappropriate use of the strong cough medication.4/18/2008 10:20:04 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10922/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10923/Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach last month announced the appointment of Janet Woodcock, MD, as director of the agency's Center for Drug Evaluation and Research(CDER), a position she has held previously.4/18/2008 10:20:04 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10923/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10096/Citing such false claim as "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications" and "Greatest STD Protection Without Condoms" (SlicPlus), the FDA issued Warning Letters to six U.S. companies and one foreign individual for marketing misbranded and unapproved drugs over the Internet.4/18/2008 10:17:04 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10096/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10925/The FDA announced that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death.3/20/2008 10:18:12 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10925/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10927/Reacting to emerging evidence of a link between the smoking cessation drug Chantix (varenicline) and serious neuropsychiatric symptoms, the FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings.3/20/2008 10:18:12 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10927/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10926/The FDA said that it would take enforcement action against companies marketing unapproved injectable colchicine, used to treat gout. Colchicine is a highly toxic drug, especially when given intravenously, and the FDA is aware of 50 reports of adverse events connected to intravenous colchicine, including 23 deaths.3/20/2008 10:18:12 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10926/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10120/The FDA announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable drug heparin, commonly used before surgery as a blood-thinning agent, due to reports of serious allergic reactions and hypotension in patients who receive high "bolus" doses of the drug.3/20/2008 10:15:12 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10120/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10142/Potential Drug Mixup Warning Concerned about possible confusion between the drugs edetate diso!=dium and edetate calcium disodium, the FDA issued a public health advisory.2/20/2008 2:39:09 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10142/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10159/Prison Sentences for Women Who Claimed ALS Cure The FDA Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease.1/24/2008 1:37:24 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10159/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10184/At the behest of the FDA, U.S. Marshals seized more than $300,000 worth of products, including an antifungal product sold as NC Solution, other drugs for human or animal use, dietary supplements, and ingredients of those products.12/20/2007 4:54:12 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10184/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10199/FDA Halts Marketing of Unapproved Hydrocone Products Companies marketing unapproved drug products containing the narcotic hydrocone must cease or they will be subject to enforcement action, the FDA announced.11/19/2007 11:20:33 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10199/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10224/FDA Warns Melanotan II Maker The FDA issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc.10/18/2007 12:26:19 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10224/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10293/Planning for Flu Outbreaks The FDA issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use.7/13/2007 2:39:36 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10293/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10321/Online Counterfeit Drug Concerns6/19/2007 10:15:44 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10321/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10336/FDA Moves to Stop Marketing of Nausea and Vomiting Drug The FDA announced that companies must cease manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride.5/18/2007 9:12:30 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10336/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10373/Xolair to Get Black Box Warning The FDA requested that Genentech, Inc.3/21/2007 3:50:21 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10373/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10400/FDA to Strengthen Drug Safety The FDA has made recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program that are designed to broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.2/20/2007 2:43:22 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10400/http://www.uspharmacist.com/content/d/fda_fast_facts/c/10436/Warnings Issued Regarding Rituxan Safety Concern in New Patient Population The FDA is alerting health care professionals and patients treated with Rituxan (rituximab), manufactured by Genentech, to reports of an emerging risk of a serious side effect.1/23/2007 1:35:35 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/10436/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11499/US  Pharm .12/22/2006 3:48:52 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11499/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11519/2006;11:78.11/22/2006 10:17:14 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11519/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11547/E.10/20/2006 9:12:09 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11547/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11570/New Warnings for Dexedrine FDA and GlaxoSmith­ Kline have announced changes to the boxed warning, warning, and precautions sections of the prescribing information for Dexedrine (dextroamphetamine sulfate), an approved treatment for attention-deficit/hyperactivity disorder and narcolepsy.9/22/2006 2:43:26 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11570/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11578/Plans Announced for the Approval of OTC Emergency Contraception FDA announced that it is working with Duramed to discuss a framework for the approval of Plan B (levonorgestrel) as an OTC emergency contraceptive.8/25/2006 10:15:30 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11578/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11610/Tysabri Marketing Allowed to Resume The Biogen-Idec drug Tysabri (natalizumab) may be marketed subject to a special restricted distribution program, FDA announced in June.7/20/2006 1:37:00 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11610/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11629/2006;6:82.6/20/2006 4:53:29 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11629/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11630/6/20/2006 8:02:48 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11630/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11664/US Pharm .5/15/2006 12:32:02 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11664/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11682/US Pharm .4/17/2006 8:05:12 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11682/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11717/US Pharm .2/20/2006 11:19:47 AMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11717/http://www.uspharmacist.com/content/d/fda_fast_facts/c/11745/US Pharm .1/17/2006 1:37:19 PMhttp://www.uspharmacist.com/content/d/fda_fast_facts/c/11745/