BLA 761147, held by Accord Biopharma Inc.. Pegfilgrastim-Pccg.
As of Nov 13, 2026, BLA 761147 (Ennumo), held by Accord Biopharma Inc., was first approved by FDA on May 7, 2026, with 0 approved supplements and 3 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2026 | Original application | Approved |
| Letter | Product | Now |
|---|---|---|
| Aug 5, 2025 | BLA 761147Facility Inspections | Unapproved |
| Oct 29, 2024 | INTPSFacility Inspections | Unapproved |
| Apr 5, 2024 | INTPSFacility Inspections | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ennumo6MG/0.6ML ยท injectable;subcutaneous | Pegfilgrastim-Pccg | 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
