BLA 761099, held by Pfizer Inc. Bevacizumab-Bvzr.
As of Nov 13, 2026, BLA 761099 (Zirabev), held by Pfizer Inc, was first approved by FDA on Jun 27, 2019, with 4 approved supplements and 0 published complete response letters.
ZIRABEV is a vascular endothelial growth factor inhibitor indicated for the treatment of:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jun 27, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zirabev100MG/4ML · injectable;injection | Bevacizumab-Bvzr | Rx |
| Zirabev400MG/16ML · injectable;injection | Bevacizumab-Bvzr | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2024 | Supplement 12Labeling · Standard review | Approved | |
| Feb 17, 2023 | Supplement 10Bioequivalence | Approved | |
| Feb 9, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 9, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Jun 27, 2019 | Original applicationNew formulation or manufacturer · 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
