Information on Erythropoiesis-Stimulating Agents (ESAs)
Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp)

Update

In August, 2008, Amgen submitted labeling supplements for Epogen/Procrit and Aranesp in response to FDAs Safety Labeling Change Order, issued under the authority of section 505(o)(4)(E) of the Federal Food, Drug and Cosmetic Act (FDCA).  FDA approved these changes, which include the replacement of the existing Patient Package Insert with a Medication Guide and the revision of the Boxed Warning, Indications and Usage, Warnings and Dosage and Administration sections of the package insert. Access to the approval letter and labeling are provided below. 

Questions and Answers on Medication Guides for ESAs (12/2/2008)

Aranesp Information

• Package Insert (labeling)
• Medication Guide
• Approval History for Aranesp from Drugs@FDA

Epogen and Procrit Information

• Package Insert (labeling)
  • Epogen
  • Procrit
• Medication Guides
  • Epogen
  • Procrit
• Approval History for Epogen and Procrit from Drugs@FDA

Eprex Information

• Early Communication about an Ongoing Safety Review: Epoetin alfa (9/26/2008) FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.

Historical Information

Report Adverse Events to MedWatch  

Back to Top     Back to Drug Index

PDF requires the free Adobe Acrobat Reader

Date created: November 16, 2006, updated December 2, 2008

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research