Ziextenzo

For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. BLA 761045, held by Sandoz Inc. Pegfilgrastim-Bmez.

As of Nov 13, 2026, BLA 761045 (Ziextenzo), held by Sandoz Inc, was first approved by FDA on Nov 4, 2019, with 4 approved supplements and 1 published complete response letter.

First approved: Nov 4, 2019
Review: Standard
Supplements approved: 4
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

ZIEXTENZO is a leukocyte growth factor indicated to

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). Limitations of Use ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.

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
Nov 4, 2019	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jun 24, 2016	LA-EP2006Clinical Pharmacology, Product Quality, Container Label And Carton Labeling	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ziextenzo6MG/0.6ML · injectable;injection	Pegfilgrastim-Bmez	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 12, 2026	Supplement 17Labeling · Standard review	Approved	Label Letter
Feb 28, 2024	Supplement 14Biosimilar	Approved	Label Letter
Oct 9, 2023	Supplement 11Manufacturing	Approved	Letter Label
Mar 12, 2021	Supplement 6Labeling · Standard review	Approved	Letter Label
Nov 4, 2019	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: BLA 761045
Drugs@FDA: Overview at FDA
Company: Sandoz

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