What's New: Drugs RSS Feed What's New at CDER http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Drugs/rss.xml en-us Fri, 12 Mar 2010 11:10:00 -0500 cderwebmaster@fda.hhs.gov (CDER Webmaster) FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug [03-12-2010] The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. Fri, 12 Mar 2010 11:10:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm New and Generic Drug Approvals Updated 3/11/2010 Thu, 11 Mar 2010 16:06:00 -0500 http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm Current Drug Shortages Current Drug Shortages: Propofol Injection (updated) 3/11/2010, Gemifibrozil Tablets 3/9/2010, Heparin Sodium Large Volume Premixed Infusion Solutions (updated) 3/8/2010, Cerezyme (imiglucerase) Injection (updated) 3/2/2010, Propofol Injection 3/1/2010, Ephedrine Injection 2/25/2010, Propofol Injection (updated) 2/24/2010, Acyclovir Tablets and Capsules (updated) 2/22/2010, Technetium Tc99m Generators (updated) 2/18/2010, Vecuronium Injection (updated) 2/12/2010, Thyroid (desiccated) tablets 2/12/2010, Mexiletine Capsules (150mg, 200mg, and 250mg) 2/12/2010 Thu, 11 Mar 2010 15:46:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm Drugs@FDA Data Files Data files updated through March 10, 2010. Wed, 10 Mar 2010 14:49:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures Wed, 10 Mar 2010 14:16:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm Paragraph IV Patent Certifications Updated list. Tue, 09 Mar 2010 15:35:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm047676.htm Pediatric Exclusivity Statistics Updated list. Tue, 09 Mar 2010 15:28:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm Status of OTC Rulemakings Updated list. Fri, 05 Mar 2010 11:28:00 -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 Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Updated list. Fri, 05 Mar 2010 08:05:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872.htm ANDA (Generic) Drug Approvals Updated listing. Thu, 04 Mar 2010 08:55:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/ucm2007009.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/ucm2007009.htm Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes Mon, 01 Mar 2010 14:41:00 -0500 http://www.fda.gov http://www.fda.gov National Drug Code Directory The National Drug Code has been updated with data through February 2010. Mon, 01 Mar 2010 08:40:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm Non-Inferiority Clinical Trials Fri, 26 Feb 2010 08:40:00 -0500 http://www.fda.gov http://www.fda.gov FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone). Thu, 25 Feb 2010 10:49:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201418.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201418.htm FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine) [01-29-2010] The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Thu, 25 Feb 2010 08:42:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199169.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199169.htm FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms The U.S. Food and Drug Administration (FDA) is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir). Wed, 24 Feb 2010 10:05:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201221.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm201221.htm Additions/Deletions for Prescription and OTC Drug Product Lists The list has been updated through August 2009. Mon, 22 Feb 2010 16:20:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm Orange Book Current Cumulative Supplement January 2010 Cumulative Supplement Mon, 22 Feb 2010 16:18:00 -0500 http://www.fda.gov http://www.fda.gov Information for Healthcare Professionals: Cefepime (marketed as Maxipime) The purpose of this communication is to share information about the FDA’s continuing safety review about the potential increased mortality in patients treated with cefepime. Cefepime is a cephalosporin antibacterial and is a member of the β–lactam class of antibacterial drugs. Mon, 22 Feb 2010 15:29:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm167254.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm167254.htm FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs) Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma. Mon, 22 Feb 2010 09:03:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm