Granix

For non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with…. BLA 125294, held by Sicor Biotech. Tbo-Filgrastim.

As of Nov 13, 2026, BLA 125294 (Granix), held by Sicor Biotech, was first approved by FDA on Aug 29, 2012, with 8 approved supplements and 0 published complete response letters.

First approved: Aug 29, 2012
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jul 31, 2018	Supplement 45Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric CDTL Review
Aug 29, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms

Product	Active ingredient	Marketing
Granix300MCG/0.5ML · injectable; injection	Tbo-Filgrastim	Rx
Granix480MCG/0.8ML · injectable; injection	Tbo-Filgrastim	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2023	Supplement 58Labeling · Standard review	Approved	Letter Label
Oct 9, 2019	Supplement 48Labeling · Standard review	Approved	Letter
Mar 28, 2019	Supplement 46Labeling · Standard review	Approved	Label Letter
Jul 31, 2018	Supplement 45Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review Pediatric CDTL Review
Jun 21, 2017	Supplement 42Labeling · Standard review	Approved	Letter Label
Feb 2, 2017	Supplement 40Labeling · Standard review	Approved	Letter Label
Dec 19, 2014	Supplement 35Labeling · Standard review	Approved	Label
Jul 19, 2013	Supplement 7Labeling · Standard review	Approved	Label Letter
Aug 29, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: BLA 125294
Drugs@FDA: Overview at FDA
Company: Sicor Biotech

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