Drugs
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.
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
Related Information
- Questions and Answers on Medication Guides for Erythropoiesis-Stimulating Agents (ESAs)
- Historical Information on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp)
- Early Communication about an Ongoing Safety Review of 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.
Labeling and Regulatory History from Drugs@FDA
Darbepoetin alfa (marketed as Aranesp)
- Approval History for Darbepoetin alfa (marketed as Aranesp)
- Aranesp (Darbepoetin alfa) Prescribing Information
FDA Approved: 11-19-08 - Arensep (Darbepoetin alfa) Medication Guide
FDA Approved: 11-19-08 - Aranesp Medguide Letter (PDF - 37KB)
Labeling and Regulatory History from Drugs@FDA
Epoetin alfa (marketed as Procrit, Epogen)
- EPOGEN (Epoetin alfa) Prescribing Information
- Procrit (Epoetin alfa) Prescribing Information
- Epogen (Epoetin alfa) Medication Guide
FDA Approved: 11-19-08 - Procrit (epoetin alfa) Medication Guide
FDA Approved: 11-19-08 - Epogin/Procrit Medguide Letter (PDF - 37KB)
- Approval History for Epogen and Procrit
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