U.S. License Holder:
Amgen
Date of License:
June-01-1989
Last Update:
Sep-30-2024
FDA-Approved Indications
EPOGEN / PROCRIT (epoetin alfa) is an erythropoiesis-stimulating agent (ESA) indicated for:
Treatment of anemia due to:
Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis;
Zidovudine in patients with Human Immunodeficiency Virus- (HIV) infection;
The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy;
Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Retacrit®: Hospira/Pfizer (May-2018)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Abseamed (Medice Arzneimittel Pütter) (August-2007) Binocrit (Sandoz) (August-2007) Epoetin alfa Hexal (Hexal) (August-2007) Retacrit (epoetin zeta) (Hospira) (December-2007) Silapo (epoetin zeta) (STADA) (December-2007)
Biosimilars Approved In Australia
Novicrit (epoetin lambda) (Sandoz) (January-2010)
Biosimilars Approved In Japan
Epoetin alfa BS (JCR Pharmaceuticals) (January-2010)