Nivestym

Treats acute myeloid leukemia (AML). BLA 761080, held by Hospira Inc. Filgrastim-Aafi.

As of Nov 13, 2026, BLA 761080 (Nivestym), held by Hospira Inc, was first approved by FDA on Jul 20, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NIVESTYM is a leukocyte growth factor indicated to

Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 20, 2018	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label Pediatric CDTL Review

Products

4 strengths and forms

Product	Active ingredient	Marketing
Nivestym300MCG/ML · vial;single-dose	Filgrastim-Aafi	Rx
Nivestym480MCG/1.6ML · vial;single-dose	Filgrastim-Aafi	Rx
Nivestym300MCG/0.5ML · injectable;injection	Filgrastim-Aafi	Rx
Nivestym480MCG/0.8ML · injectable;injection	Filgrastim-Aafi	Rx

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 16, 2024	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 28, 2023	Supplement 11Labeling · Standard review	Approved	Letter Label
May 3, 2021	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 20, 2018	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label Pediatric CDTL Review

Identifiers

Application: BLA 761080
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