BLA 761111, held by Hospira Inc. Pegfilgrastim-Apgf.
As of Nov 13, 2026, BLA 761111 (Nyvepria), held by Hospira Inc, was first approved by FDA on Jun 10, 2020, with 2 approved supplements and 0 published complete response letters.
Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA is indicated in adults and pediatric patients aged newborn and older 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. NYVEPRIA is a leukocyte growth factor
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2020 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nyvepria6MG/0.6ML · injectable;injection | Pegfilgrastim-Apgf | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Apr 16, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Jun 10, 2020 | Original applicationNew active ingredient · 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
