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Retacrit FDA Approval History

FDA Approved: Yes (First approved May 15, 2018)
Brand name: Retacrit
Generic name: epoetin alfa-epbx
Dosage form: for Injection
Company: Hospira, Inc.
Treatment for: Anemia

Retacrit (epoetin alfa-epbx) is an erythropoiesis-stimulating agent (ESA) biosimilar to Epogen/Procrit (epoetin alfa) indicated for treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

Development timeline for Retacrit

May 15, 2018Approval FDA Approves Retacrit (epoetin alfa-epbx) as First Epoetin Alfa Biosimilar for the Treatment of Anemia

Further information

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