VIZIMPRO
NDA 211288 · New Drug Application (NDA) Discontinued
DACOMITINIB
- Sponsor (Drugs@FDA)
- PFIZER Company: PFIZER INC (PFE)
- 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 | VIZIMPRO DACOMITINIB | TABLET;ORAL 15MG | Discontinued | – | Reference listed drug | DISCNApproved |
| 002 | VIZIMPRO DACOMITINIB | TABLET;ORAL 30MG | Discontinued | – | Reference listed drug | DISCNApproved |
| 003 | VIZIMPRO DACOMITINIB | TABLET;ORAL 45MG | Discontinued | – | Reference listed drug | DISCNApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Original 1 | Approved | priority | 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
9 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10596162Product 001 | Method of use | U-3338 | ||
| 10603314Product 001 | Method of use | U-3337 | ||
| 7772243Product 001 | Drug substance, Drug product | – | ||
| 10596162Product 002 | Method of use | U-3338 | ||
| 10603314Product 002 | Method of use | U-3337 | ||
| 7772243Product 002 | Drug substance, Drug product | – | ||
| 10596162Product 003 | Method of use | U-3338 | ||
| 10603314Product 003 | Method of use | U-3337 | ||
| 7772243Product 003 | Drug substance, Drug product | – |
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
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.
Vizimpro
DACOMITINIB · Pfizer Laboratories Div Pfizer Inc · ORAL · Version 9 · effective
Indications and usage
1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. ( 1 )
NDC products
3 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0069-0197 in openFDA (opens in a new tab) | Vizimpro dacomitinib | Pfizer Laboratories Div Pfizer Inc | TABLET, FILM COATED ORAL | NDA | From Ends |
| 0069-1198 in openFDA (opens in a new tab) | Vizimpro dacomitinib | Pfizer Laboratories Div Pfizer Inc | TABLET, FILM COATED ORAL | NDA | From Ends |
| 0069-2299 in openFDA (opens in a new tab) | Vizimpro dacomitinib | Pfizer Laboratories Div Pfizer Inc | TABLET, FILM COATED ORAL | NDA | From Ends |
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.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- 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.