IMFINZI
BLA 761069 · Biologics License Application (BLA) Prescription
DURVALUMAB
- Sponsor (Drugs@FDA)
- ASTRAZENECA UK LTD Company: ASTRAZENECA PLC (AZN)
- 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 | IMFINZI DURVALUMAB | INJECTABLE;INJECTION 50MG/ML | Prescription | – | No | Not listed |
Submissions
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 |
|---|---|---|---|---|---|---|
| Imfinzi 001durvalumab · AstraZeneca UK Ltd | 351(a) Licensed · Rx | 500MG/10ML (50MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | Orphan exclusivity expires | |
| Imfinzi 002durvalumab · AstraZeneca UK Ltd | 351(a) Licensed · Rx | 120MG/2.4ML (50MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | Orphan exclusivity expires |
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
IMFINZI
DURVALUMAB · AstraZeneca Pharmaceuticals LP · INTRAVENOUS · Version 34 · effective
Indications and usage
1 INDICATIONS AND USAGE IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. ( 1.1 ) • as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.1 ) • in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. ( 1.1 ) • as a single agent, for the treatment of adult patients with limited-sta…
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0310-4500 in openFDA (opens in a new tab) | IMFINZI Durvalumab | AstraZeneca Pharmaceuticals LP | INJECTION, SOLUTION INTRAVENOUS | BLA | From |
| 0310-4611 in openFDA (opens in a new tab) | IMFINZI Durvalumab | AstraZeneca Pharmaceuticals LP | INJECTION, SOLUTION INTRAVENOUS | BLA | From |
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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.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
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.