What's New at CDER http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Drugs/rss.xml en-us Thu, 24 May 2012 11:43:00 -0500 cderwebmaster@fda.hhs.gov (CDER Webmaster) Drug Approval Listing Thu, 24 May 2012 11:43:00 -0500 http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm New/Updated Drug Shortages: NeoProfen (ibuprofen lysine) Injection 5/24/2012 Thu, 24 May 2012 05:59:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes. Tue, 22 May 2012 08:10:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Tue, 22 May 2012 08:05:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). Tue, 22 May 2012 08:02:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm297391.htm http://www.fda.gov/Drugs/DrugSafety/ucm297391.htm The list has been updated through April 2012. Mon, 21 May 2012 14:44:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm Drugs to be Discontinued: Calcitriol 1 mcg/mL Injection, Ondansetron Injection 32 mg/50 mL premixed bags, Refludan (lepirudin (rDNA)) for Injection 5/21/2012 Mon, 21 May 2012 14:29:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm April 2012 Cumulative Supplement Mon, 21 May 2012 13:52:00 -0500 http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf http://www.fda.gov April 2012 Orange Book data files, zip format. Mon, 21 May 2012 13:37:00 -0500 http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip http://www.fda.gov El lunes, 14 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) anunció que ha concluido su evaluación de un informe sobre un paciente que murió después de la primera dosis del medicamento Gilenya (fingolimod) para la esclerosis múltiple. Mon, 21 May 2012 08:33:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm304654.htm http://www.fda.gov/Drugs/DrugSafety/ucm304654.htm El 7 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público sobre el aumento en el riesgo de segundas neoplasias primarias (nuevos tipos de cáncer) en pacientes con mieloma múltiple de reciente diagnóstico, que tomaron Revlimid (lenalidomida). Thu, 17 May 2012 09:06:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm304391.htm http://www.fda.gov/Drugs/DrugSafety/ucm304391.htm FDA has updated questions and answers about the safe use of approved pancreatic enzyme products. Thu, 17 May 2012 07:56:00 -0500 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204745.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm204745.htm Thu, 17 May 2012 07:36:00 -0500 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm News and Announcements updated Wed, 16 May 2012 09:15:00 -0500 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. Tue, 15 May 2012 10:57:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm Mon, 14 May 2012 09:14:00 -0500 http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm [12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). Mon, 14 May 2012 08:07:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm284240.htm http://www.fda.gov/Drugs/DrugSafety/ucm284240.htm The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills Thu, 10 May 2012 13:49:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase. Thu, 10 May 2012 13:35:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm301616.htm http://www.fda.gov/Drugs/DrugSafety/ucm301616.htm [2-15-2012] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals; in particular, the medical imaging community, about the planned return of CardioGen-82 to the U.S. market following the voluntary recall by the manufacturer, Bracco Diagnostics, Inc., on July 25, 2011. Thu, 10 May 2012 13:28:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm291758.htm http://www.fda.gov/Drugs/DrugSafety/ucm291758.htm