What's New at CDER http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Drugs/rss.xml en-us Mon, 20 May 2013 15:08:00 -0400 cderwebmaster@fda.hhs.gov (CDER Webmaster) Drug Approval Listing Mon, 20 May 2013 15:08:00 -0400 http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm The U.S. Food and Drug Administration (FDA) is informing the public about the results of a large, combined analysis (called a meta-analysis) of clinical trials that compared patients who received the smoking cessation drug Chantix (varenicline) to patients who received a placebo (an inactive treatment). Mon, 20 May 2013 15:07:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm Update on Fungal Meningitis Mon, 20 May 2013 14:54:00 -0400 http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/ucm322734.htm http://www.fda.gov/Drugs/DrugSafety/FungalMeningitis/ucm322734.htm Drug Establishments Current Registration Download File last updated May 20, 2013 Mon, 20 May 2013 10:50:00 -0400 http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm updated through May 20, 2013. Mon, 20 May 2013 10:49:00 -0400 http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM197817.zip http://www.fda.gov Files updated: 5/20/2013. Mon, 20 May 2013 08:28:00 -0400 http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm NDC zip file updated 5/20/2013 Mon, 20 May 2013 08:23:00 -0400 http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM070838.zip http://www.fda.gov Mon, 20 May 2013 01:24:00 -0400 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm April 2013 Orange Book data files, zip format. Fri, 17 May 2013 13:54:00 -0400 http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip http://www.fda.gov The list has been updated through April 2013. Fri, 17 May 2013 13:53:00 -0400 http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm The U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. Fri, 17 May 2013 11:19:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm352085.htm http://www.fda.gov/Drugs/DrugSafety/ucm352085.htm News and Announcements updated Thu, 16 May 2013 10:55:00 -0400 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm Updated list of medication guides. Thu, 16 May 2013 10:47:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm Data files updated through May 15, 2013 Wed, 15 May 2013 14:35:00 -0400 http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Tue, 14 May 2013 10:17:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm http://www.fda.gov/Drugs/DrugSafety/ucm334033.htm The U.S. Food and Drug Administration (FDA) is alerting health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. Mon, 13 May 2013 15:09:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm350733.htm http://www.fda.gov/Drugs/DrugSafety/ucm350733.htm The U.S. Food and Drug Administration (FDA) is advising health care professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Mon, 13 May 2013 14:30:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm Updated list. Fri, 10 May 2013 09:38:00 -0400 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm The U.S. Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant, or death. Mon, 06 May 2013 12:09:00 -0400 http://www.fda.gov/Drugs/DrugSafety/ucm350062.htm http://www.fda.gov/Drugs/DrugSafety/ucm350062.htm Fri, 03 May 2013 14:34:00 -0400 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm342636.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm342636.htm