What's New at CDER http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Drugs/rss.xml en-us Wed, 16 May 2012 13:20:00 -0500 cderwebmaster@fda.hhs.gov (CDER Webmaster) Drug Approval Listing Wed, 16 May 2012 13:20:00 -0500 http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm http://www.fda.gov/Drugs/NewsEvents/ucm130961.htm New/Updated Drug Shortages: AsmanexTwisthaler, Isoniazid Tablets, Ketorolac Injection, Methylphenidate HCl, Nalbuphine HCl Injection, Odansetron Injection 2 mg/mL, Potassium Chloride Injection 2 mEq/mL, Thiotepa for Injection, Ticlopidine Tablets 5/16/2012 Wed, 16 May 2012 10:58:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm Drugs to be Discontinued: Digoxin Injection, Naltrexone Oral Tablets 5/16/2012 Wed, 16 May 2012 09:37:00 -0500 http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.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 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, 15 May 2012 09:24:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm303192.htm http://www.fda.gov/Drugs/DrugSafety/ucm303192.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 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). Wed, 09 May 2012 07:24:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm [01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML). Tue, 08 May 2012 10:18:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm http://www.fda.gov/Drugs/DrugSafety/ucm288186.htm File updated through 3/27/2012. Tue, 08 May 2012 10:08:00 -0500 http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM135169.zip http://www.fda.gov [1-12-2012] The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 on July 25, 2011 by the manufacturer, Bracco Diagnostics, Inc. Tue, 08 May 2012 10:03:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm287413.htm http://www.fda.gov/Drugs/DrugSafety/ucm287413.htm Updated list. Tue, 08 May 2012 08:05:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050006.htm Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies Mon, 07 May 2012 14:07:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050002.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050002.htm El 26 de abril del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público que, en estos momentos, no se recomienda tomar conjuntamente Victrelis (boceprevir), un inhibidor de la proteasa del virus de la hepatitis C (VHC) junto con ciertos inhibidores de la proteasa del virus de la inmunodeficiencia humana VIH reforzados con ritonavir, por la posibilidad de reducir la eficacia de los medicamentos, lo que puede desencadenar el aumento del VHC o VIH en la sangre (carga viral). Mon, 07 May 2012 08:11:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm302914.htm http://www.fda.gov/Drugs/DrugSafety/ucm302914.htm El 20 de abril del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) advirtió sobre la probabilidad de riesgos por el uso de medicamentos para la presión arterial que contienen aliskiren combinado con otros medicamentos denominados inhibidores de la enzima convertidora de angiotensina (ACEIs por sus siglas en inglés), y los bloqueadores de los receptores de angiotensina (ARBs por sus siglas en inglés) en pacientes con diabetes o problemas renales o de riñón. Tue, 01 May 2012 08:38:00 -0500 http://www.fda.gov/Drugs/DrugSafety/ucm302498.htm http://www.fda.gov/Drugs/DrugSafety/ucm302498.htm Updated statistics and exclusivity determinations list. Mon, 30 Apr 2012 14:42:00 -0500 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm