BLA 125547, held by Eli Lilly Co. Necitumumab.
As of Nov 13, 2026, BLA 125547 (Portrazza), held by Eli Lilly Co, was first approved by FDA on Nov 24, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 24, 2015 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Portrazza800MG/50ML · injectable;intra-articular, intramuscular, intravitreal | Necitumumab | Rx |
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
