CDER New April 29, 2013
FDA (U.S. Food and Drug Administration) [ http://www.fda.gov/?source=govdelivery ] *What's New on the FDA Drugs Site* *April 26, 2013* * ANDA Suitability Petition Reports [ http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120944.htm?source=govdelivery ] (updated) * Current Drug Shortages Index [ http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm?source=govdelivery ] (updated) * New Drug Shortage: Dobutamine Hydrochloride Injection [ http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314739.htm?source=govdelivery ] * New Drug Shortage: Mecasermin [rDNA origin] (Increlex) Injection [ http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314741.htm?source=govdelivery ] * Drugs to be Discontinued: Nimodipine Capsules [ http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050794.htm?source=govdelivery ] * Drug Firm Annual Registration Status Download File [ http://www.fda.gov/Drugs/InformationOnDrugs/ucm135778.htm?source=govdelivery ] (updated) * Drug Firm Annual Registration Status [ http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm?source=govdelivery ] (updated) * Drug Shortages: Additional News and Information [ http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm349561.htm?source=govdelivery ] * FDA Drug Safety Communication: Anti-seizure drug Potiga (ezogabine) linked to retinal abnormalities and blue skin discoloration [ http://www.fda.gov/Drugs/DrugSafety/ucm349538.htm?source=govdelivery ] * First-Time Generic Drug Approvals - 2013 [ http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/default.htm?source=govdelivery ] (updated) * Fraudulent Versions of Botox Found in the United States [ http://www.fda.gov/Drugs/DrugSafety/ucm349503.htm?source=govdelivery ] * MedWatch Safety Alert: Sodium Chloride Injection 0.9 percent USP, 100 mL Flexible Containers by Hospira: Recall - Particulate Matter [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349622.htm?source=govdelivery ] * National Drug Code Directory [ http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm?source=govdelivery ] (updated)














