U.S. License Holder:
Hospira / Pfizer
Date of License:
May-15-2018
Last Update:
Nov-30-2023
FDA-Approved Indications
RETACRIT (epoetin alfa-epbx) is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to: (i) Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis; (ii) Zidovudine in patients with HIV-infection; (iii) The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy;
Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Retacrit (epoetin zeta) (Hospira) (December-2007)