Treats acute myeloid leukemia (AML) Reduce the duration of neutropenia and…. BLA 761027, held by Accord Biopharma Inc.. Filgrastim-Laha.
As of Nov 13, 2026, BLA 761027 (Filkri), held by Accord Biopharma Inc., was first approved by FDA on Jan 15, 2026, with 0 approved supplements and 1 published complete response letter.
FILKRI is a leukocyte growth factor indicated to Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2026 | Original application | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 26, 2025 | INTP1Facility Inspections | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Filkri300MCG/0.5ML · injectable;injection | Filgrastim-Laha | Rx |
| Filkri480MCG/0.8ML · injectable;injection | Filgrastim-Laha | Rx |
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
