REMS File
(contact us for more information on Aranesp)
| Brand Name | Aranesp |
| Generic Name | darbepoetin alfa |
| Marketed by | Amgen |
| NDA/BLA Holder | Amgen |
| NDA/BLA Number | BLA 103951/5197 |
| NDA/BLA Approval Date | 9/17/2001 |
| Status | Approved |
| Review Classification | Not Applicable |
| REMS Approval Date | 2/16/2010 |
| Class REMS | ESA |
| REMS Source Document | |
| Boxed Warning? | |
| Boxed Warning | |
| Indication | |
| Route of Administration | |
| Mechanism of Action | |
| Risks | |
| Risks (MedGuide Language) | |
| Approved Labeling | |
| Medication Guide? | |
| Medication Guide | |
| Medication Guide Version | |
| Communication Plan? | |
| Communication Plan | |
| Elements to Assure Safe Use? | |
| Elements to Assure Safe Use | |
| Implementation System? | |
| Implementation System | |
| Assessment Program | |
| Assessment Program Timeline | |
| Branded Program | |
| Program Description | |
| Link to Branded Program | |
| Deemed/Approved | |
| Approval Letters |
Sources
REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)
Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)
Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)
Previous page: REMS Directory Next page: REMS White Papers