For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. BLA 125031, held by Amgen. Pegfilgrastim.
As of Nov 13, 2026, BLA 125031 (Neulasta), held by Amgen, was first approved by FDA on Jan 31, 2002, with 29 approved supplements and 0 published complete response letters.
Neulasta is a leukocyte growth factor indicated in adult and pediatric patients 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 Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2015 | Supplement 180Efficacy (new indication or use) · Priority review | Approved | |
| Sep 15, 2005 | Supplement 52Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2002 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Neulasta6MG/0.6ML · syringe | Pegfilgrastim | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2026 | Supplement 210Labeling · Standard review | Approved | |
| Aug 18, 2025 | Supplement 209Manufacturing | Approved | |
| Feb 2, 2021 | Supplement 203Labeling · Standard review | Approved | |
| Jan 5, 2021 | Supplement 202Labeling · Standard review | Approved | |
| Nov 18, 2020 | Supplement 201Labeling · Standard review | Approved | |
| Jan 6, 2020 | Supplement 199Labeling · Standard review | Approved | |
| Apr 16, 2019 | Supplement 198Labeling · Standard review | Approved | |
| Jun 18, 2018 | Supplement 193Labeling · Standard review | Approved | |
| Dec 9, 2017 | Supplement 191Labeling · Standard review | Approved | |
| Dec 9, 2017 | Supplement 189Labeling · Standard review | Approved | |
| Apr 28, 2016 | Supplement 184Labeling · Standard review | Approved | |
| Nov 13, 2015 | Supplement 180Efficacy (new indication or use) · Priority review | Approved | |
| Sep 23, 2015 | Supplement 181Labeling · Standard review | Approved | |
| Sep 23, 2015 | Supplement 179Labeling · Standard review | Approved | |
| Sep 23, 2015 | Supplement 170Labeling · Standard review | Approved | |
| Dec 23, 2014 | Supplement 175Manufacturing | Approved | |
| May 25, 2012 | Supplement 142Labeling · Standard review | Approved | |
| Jun 3, 2011 | Supplement 130Labeling · Standard review | Approved | |
| Feb 17, 2010 | Supplement 120Labeling · Standard review | Approved | |
| Nov 14, 2008 | Supplement 105Labeling · Standard review | Approved | |
| Nov 14, 2008 | Supplement 91 | Approved | |
| Apr 16, 2008 | Supplement 95Labeling · Standard review | Approved | |
| Jul 23, 2007 | Supplement 82Labeling · Standard review | Approved | |
| Oct 25, 2006 | Supplement 72 | Approved | |
| Sep 15, 2005 | Supplement 52Efficacy (new indication or use) · Standard review | Approved | |
| Jan 24, 2005 | Supplement 51Labeling · Standard review | Approved | |
| Dec 17, 2004 | Supplement 48Labeling · Standard review | Approved | |
| Nov 24, 2004 | Supplement 43Labeling · Standard review | Approved | None posted |
| Nov 3, 2004 | Supplement 39Labeling · Standard review | Approved | None posted |
| Jan 31, 2002 | Original applicationNew molecular entity · Standard review | Approved |
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
