For non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with…. BLA 761173, held by Fresenius Kabi USA. Pegfilgrastim-Fpgk.
As of Nov 13, 2026, BLA 761173 (Stimufend), held by Fresenius Kabi USA, was first approved by FDA on Sep 1, 2022, with 3 approved supplements and 0 published complete response letters.
Stimufend 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 Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 1, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Stimufend6MG/0.6ML · solution; injection | Pegfilgrastim-Fpgk | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Mar 26, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Sep 29, 2023 | Supplement 2Biosimilar · Standard review | Approved | |
| Sep 1, 2022 | Original application | 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
