FDA approved the original biologics license application for FILKRI on January 15, 2026, sponsored by ACCORD BIOPHARMA INC.. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761027
- Sponsor
- ACCORD BIOPHARMA INC.
- Original approval
- Review
- standard review
- Active ingredient
- filgrastim-laha
Browse every approval whose brand starts with F, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| filgrastim-laha 300MCG/0.5ML | INJECTABLE | INJECTION | Prescription |
| filgrastim-laha 480MCG/0.8ML | INJECTABLE | INJECTION | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to ACCORD BIOPHARMA INC.
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