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Retacrit

epoetin alfa-epbx

351(k) Biosimilar

Overview

Source: Purple Book
Proprietary name
Retacrit
Proper name
epoetin alfa-epbx
Licence type
351(k) Biosimilar
BLA number
125545
Applicant
Hospira Inc., a Pfizer Company
Center
CDER
Presentations
7
First licensure
—
351(k) biosimilar pathway. This product was licensed as highly similar to a reference product, with no clinically meaningful differences in safety, purity or potency. It is licensed as a biosimilar but is not designated interchangeable, so substitution requires the prescriber.

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
10,000UNITS/ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx May 15, 2018
2,000UNITS/ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx May 15, 2018
20,000UNITS/2ML (10,000UNITS/ML) Injection Intravenous, Subcutaneous Multi-Dose Vial Rx June 30, 2020
20,000UNITS/ML Injection Intravenous, Subcutaneous Multi-Dose Vial Rx June 30, 2020
3,000UNITS/ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx May 15, 2018
4,000UNITS/ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx May 15, 2018
40,000UNITS/ML Injection Intravenous, Subcutaneous Single-Dose Vial Rx May 15, 2018

Reference product

Source: Purple Book

This product is licensed with reference to Procrit (epoetin alfa).

View reference product Search the small-molecule catalogue

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity