Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|
| Jul 24, 2026 | Original applicationNew molecular entity, new combination · Standard review | Approved | ReviewLetterLabel |
Complete Response Letters
FDA's published letters for this application; each opens the letterProducts
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Lytenava1.25MG (0.05ML of 25MG/ML · vial;single-dose | Bevacizumab-Vikg | Rx |
Identifiers
- Application
- BLA 761320
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
