BLA 761165, held by Sandoz Inc. Ranibizumab-Eqrn.
As of Nov 13, 2026, BLA 761165 (Cimerli), held by Sandoz Inc, was first approved by FDA on Aug 2, 2022, with 1 approved supplement and 0 published complete response letters.
CIMERLI is indicated for the treatment of patients with: CIMERLI, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cimerli0.3MG(6MG/ML) · injectable;injection | Ranibizumab-Eqrn | Rx |
| Cimerli0.5MG(10MG/ML) · injectable;injection | Ranibizumab-Eqrn | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2024 | Supplement 5Bioequivalence | Approved | |
| Aug 2, 2022 | 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
