What's New at CDER http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Drugs/rss.xml en-us Fri, 06 Nov 2009 14:35:00 -0500 cderwebmaster@fda.hhs.gov (CDER Webmaster) Updated list. Fri, 06 Nov 2009 14:35:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm On October 30th, 2009, FDA issued an amendment to the Emergency Use Authorization for Tamiflu that included dosing recommendations based on weight for infants less than 1 year of age. Fri, 06 Nov 2009 13:21:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183870.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183870.htm Collaborating to Reduce Preventable Harm from Medications Fri, 06 Nov 2009 12:50:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm Current Drug Shortages: Propofol Injection 11/6/2009, Pentothal (thiopental) Injection 11/4/2009, Mitomycin for injection (updated) 10/28/2009, Methotrexate injection updated (10/28/2009), 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, Tamiflu (oseltamivir phosphate) powder, for oral suspension, 12mg/ml 10/6/2009 Fri, 06 Nov 2009 09:58:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm Updated list. Fri, 06 Nov 2009 08:55:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm2007037.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm2007037.htm Updated listing Fri, 06 Nov 2009 08:53:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm070005.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm070005.htm Updated list. Fri, 06 Nov 2009 08:49:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050002.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050002.htm Updated list. Fri, 06 Nov 2009 08:43:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm This Alert highlights important revisions to the Warnings, Dosage and Administration, Contraindications, and Clinical Pharmacology sections of the full prescribing information for ceftriaxone (Rocephin and its generics).  Thu, 05 Nov 2009 11:40:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084263.htm DIA/FDA Computational Science Meeting, March 22-23, 2010. DIA/FDA Statistics Forum, April 19-20, 2010. Thu, 05 Nov 2009 09:20:00 -0500 http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm http://www.fda.gov/Drugs/NewsEvents/ucm132703.htm Updated list. Wed, 04 Nov 2009 14:10:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872.htm Data files updated through November 4, 2009. Wed, 04 Nov 2009 11:11:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm Wed, 04 Nov 2009 10:09:00 -0500 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992 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 Tue, 03 Nov 2009 15:04:00 -0500 http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm100228.htm Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions Mon, 02 Nov 2009 17:48:00 -0500 http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm188629.htm http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm188629.htm Mon, 02 Nov 2009 14:41:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/ucm188693.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/ucm188693.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. Mon, 02 Nov 2009 14:05:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm188656.htm Procter and Gamble Warning Letter added Mon, 02 Nov 2009 09:34:00 -0500 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055773.htm Drugs to be Discontinued: FASLODEX* (fulvestrant) Injection (11/2/2009) Mon, 02 Nov 2009 09:03:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm The National Drug Code has been updated with data through October 30th. Fri, 30 Oct 2009 14:09:00 -0400 http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm