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Epogen News

'BioSimilar' Drug Retacrit (Epoetin Alfa-epbx) Approved to Treat Certain Types of Anemia

TUESDAY, May 15, 2018 – Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit. A biosimilar,...

FDA Medwatch Alert: Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing...

FDA Medwatch Alert: Epogen (epoetin alfa) - Mar 9, 2007

[UPDATE 03/09/2007] FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit...

FDA Medwatch Alert: Epogen (epoetin alfa) - Dec 1, 2005

[Posted 12/01/2005] Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the...

FDA Medwatch Alert: Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs. The...

FDA Medwatch Alert: Epoetin alfa

Posted 09/23/2008] 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. The clinical...

FDA Medwatch Alert: Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

[Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT...

FDA Medwatch Alert: Erythropoiesis Stimulating Agents:Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

[Posted 11/08/2007] FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain...

FDA Medwatch Alert: Erythropoiesis Stimulating Agents

[UPDATE 03/09/2007] FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit...

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