PORTRAZZA
BLA 125547 · Biologics License Application (BLA) Prescription
NECITUMUMAB
- Sponsor (Drugs@FDA)
- ELI LILLY CO Company: ELI LILLY & Co (LLY)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | PORTRAZZA NECITUMUMAB | INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL 800MG/50ML | Prescription | – | No | Not listed |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Original 1 | Approved | standard | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
No Orange Book patents are listed for this application.
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Purple Book licensure
| Product | Licence | Strength and presentation | Licensed on | First licensure | Reference product | Exclusivity |
|---|---|---|---|---|---|---|
| Portrazza 001necitumumab · Eli Lilly and Company | 351(a) Licensed · Rx | 800MG/50ML (16MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | Orphan exclusivity expires |
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
No NDC directory product carries this application number.
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Purple Book (opens in a new tab)Licence: public-domain. Purple Book purplebook-2026-09.csv.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.