Retacrit

Treats anemia due to o Chronic Kidney Disease (CKD). BLA 125545, held by Hospira Inc. Epoetin Alfa-Epbx.

As of Nov 13, 2026, BLA 125545 (Retacrit), held by Hospira Inc, was first approved by FDA on May 15, 2018, with 4 approved supplements and 0 published complete response letters.

First approved: May 15, 2018
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RETACRIT is an erythropoiesis-stimulating agent (ESA) indicated for:

Treatment of anemia due to o Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis. o Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection. o 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. Limitations of Use RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 30, 2020	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 15, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

5 strengths and forms

Product	Active ingredient	Marketing
Retacrit2,000UNITS/ML · injectable;injection	Epoetin Alfa-Epbx	Rx
Retacrit3,000UNITS/ML · injectable;injection	Epoetin Alfa-Epbx	Rx
Retacrit4,000UNITS/ML · injectable;injection	Epoetin Alfa-Epbx	Rx
Retacrit10,000UNITS/ML · injectable;injection	Epoetin Alfa-Epbx	Rx
Retacrit40,000UNITS/ML · injectable;injection	Epoetin Alfa-Epbx	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 4, 2024	Supplement 32Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 18, 2023	Supplement 22Labeling · Standard review	Approved	Letter Label
Jun 30, 2020	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 18, 2019	Supplement 3Labeling · Standard review	Approved	Label Letter
May 15, 2018	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: BLA 125545
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters