BLA 761382, held by Sandoz Inc. Aflibercept-Abzv.
As of Nov 13, 2026, BLA 761382 (Enzeevu), held by Sandoz Inc, was first approved by FDA on Oct 22, 2026, with 2 approved supplements and 0 published complete response letters.
ENZEEVU is indicated for the treatment of: ENZEEVU is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2026 | Original application | Approved | |
| Aug 9, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Enzeevu2MG(0.05ML of 40MG/ML) · injectable;injection | Aflibercept-Abzv | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2026 | Original application | Approved | |
| Feb 12, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Feb 10, 2025 | Supplement 3Biosimilar | Approved | |
| Aug 9, 2024 | 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
