For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. BLA 761039, held by Coherus Biosciences Inc. Pegfilgrastim-Cbqv.
As of Nov 13, 2026, BLA 761039 (Udenyca), held by Coherus Biosciences Inc, was first approved by FDA on Nov 2, 2018, with 7 approved supplements and 1 published complete response letter.
UDENYCA 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 UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2023 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2023 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 28, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Nov 2, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 9, 2017 | CHS-1701Immunogenicity, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Udenyca6MG/0.6ML · injectable;injection | Pegfilgrastim-Cbqv | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2023 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Mar 3, 2023 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Nov 28, 2022 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jun 7, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Feb 12, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Oct 17, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Apr 16, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Nov 2, 2018 | Original applicationNew formulation or manufacturer · 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
