BLA 761480, held by Lupin Limited. Ranibizumab-Hkdz.
As of Nov 14, 2026, BLA 761480 (Ranluspec), held by Lupin Limited, was first approved by FDA on Jun 2, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 2026 | Original applicationNew active ingredient · Standard review | Approved |
| Ranluspec10MG/ML · injection | Ranibizumab-Hkdz | Rx |
| Ranluspec6MG/ML · injection | Ranibizumab-Hkdz | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
