What's New at CDER http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Drugs/rss.xml en-us Fri, 20 Nov 2009 17:47:00 -0500 cderwebmaster@fda.hhs.gov (CDER Webmaster) FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Fri, 20 Nov 2009 17:47:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm191650.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm191650.htm Fri, 20 Nov 2009 15:15:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm191472.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm191472.htm Dr. Charles McKay, Hopewell, Eisai and Shire Warning Letters added Fri, 20 Nov 2009 14:01:00 -0500 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm Fri, 20 Nov 2009 10:11:00 -0500 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073507 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073507 Information for Healthcare Professionals - Mandatory Adverse Event Reporting for Emergency Use of Peramivir Under EUA - 10/23/2009 Peramivir IV Questions and Answers for Health Care Providers - 10/30/2009 Thu, 19 Nov 2009 20:35:00 -0500 http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm Current Drug Shortages: Indocin I. V. (indomethacin for injection) (11/17/2009), Thiotepa 15mg injection 11/17/2009, Methotrexate injection (updated) 11/17/2009, Mitomycin for injection (updated) 11/17/2009, Fabrazyme (agalsidase beta)(updated) 11/17/2009, Cerezyme (imiglucerase) Injection (updated) 11/17/2009, Vecuronium Injection (11/17/2009), Propofol Injection (11/17/2009), Norpace CR 100 mg and 150 mg capsules (11/13/2009), Pentothal (thiopental) Injection (11/4/2009), Azactam 1 gram and 2 gram (aztreonam for injection)(updated) 10/28/2009, Technetium Tc99m Generators (updated) 10/27/2009, Fabrazyme (agalsidase beta) updated 10/19/2009 Thu, 19 Nov 2009 14:16:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm Data files updated through November 18, 2009. Wed, 18 Nov 2009 14:49:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm Updated list. Wed, 18 Nov 2009 08:21:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm The U.S. Food and Drug Administration (FDA) is recommending that the co-administration of clopidogrel (Plavix), a drug used to prevent blood clot formation, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid, be avoided because omeprazole reduces the effectiveness of clopidogrel. Tue, 17 Nov 2009 10:17:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190784.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190784.htm The U.S. Food and Drug Administration (FDA) has new data showing that omeprazole (Prilosec/Prilosec OTC)—a medicine used to reduce stomach acid—reduces the anti-blood clotting effect of clopidogrel (Plavix) by almost half when these two medicines are taken by the same patient. Tue, 17 Nov 2009 10:16:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm190825.htm http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm190825.htm FDA is alerting the public to new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. Tue, 17 Nov 2009 10:15:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190787.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190787.htm The Orange Book lists drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. Mon, 16 Nov 2009 14:06:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm Mon, 16 Nov 2009 13:43:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/UCM086233 http://www.fda.gov/Drugs/InformationOnDrugs/UCM086233 The list has been updated through August 2009. Mon, 16 Nov 2009 13:38:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm Mon, 16 Nov 2009 11:02:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm190622.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm190622.htm Electronic Orange Book (EOB) Query data files updated 8/16/2009. Fri, 13 Nov 2009 14:25:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm FDA is warning healthcare professionals about the potential for foreign particle contamination of several products manufactured by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases. Fri, 13 Nov 2009 14:24:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190400.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190400.htm The Food and Drug Administration (FDA) has reviewed 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. Fri, 13 Nov 2009 11:00:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190302.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190302.htm FDA has approved revisions to the drug label for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Fri, 13 Nov 2009 10:07:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm Files updated for 3rd Quarter 2009. Thu, 12 Nov 2009 15:00:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm2007046.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm2007046.htm