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Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
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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