Prescription medicine
Dacomitinib Brand names: Vizimpro
Dacomitinib (Vizimpro) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: the dacomitinib FDA label on DailyMed (effective June 23, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 211288 record on Drugs@FDA; every dacomitinib label on DailyMed.
Highlights of the record
FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVIZIMPRO 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) ].
Forms and strengths
- 15 mg
- 30 mg
- 45 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 27, 2018 Vizimpro, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 27, 2032 Vizimpro tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 746 through July 30, 2026
What is dacomitinib used for?
From the label: indications and usageVIZIMPRO 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.
Conditions named in the indications of dacomitinib's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Vizimpro), Pfizer Laboratories Div Pfizer Inc, effective June 23, 2026 (SPL set 4ab27d2f-e385-4e9c-b324-fa69c10b855a), via openFDA; the full label on DailyMed
What does the patient leaflet for dacomitinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid during treatment with VIZIMPRO?Minimize exposure to sunlight. VIZIMPRO can cause skin reactions. See “What are the possible side effects of VIZIMPRO?”
From the patient leaflet: How should I store VIZIMPRO?Store VIZIMPRO at 20 °C to 25 °C (68 °F to 77 °F). Keep VIZIMPRO and all medicines out of the reach of children.
Source: FDA drug label (Vizimpro), Pfizer Laboratories Div Pfizer Inc, effective June 23, 2026 (SPL set 4ab27d2f-e385-4e9c-b324-fa69c10b855a), via openFDA; the full label on DailyMed
Is there a generic for dacomitinib (Vizimpro)?
No generic dacomitinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Vizimpro tablets: the compound patent runs to September 27, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is dacomitinib in shortage?
No dacomitinib presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated June 8, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Vizimpro, Tablet, 15 mg (NDC 0069-0197-30) | Pfizer Inc. | To Be Discontinued | June 8, 2026 |
| Vizimpro, Tablet, 30 mg (NDC 0069-1198-30) | Pfizer Inc. | To Be Discontinued | June 8, 2026 |
| Vizimpro, Tablet, 45 mg (NDC 0069-2299-30) | Pfizer Inc. | To Be Discontinued | June 8, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the dacomitinib label say about other medicines?
The dacomitinib label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | warnings and precautions | Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea. |
| Loperamide | warnings and precautions | Promptly initiate anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride with atropine sulfate) for diarrhea. |
Source: FDA drug label (Vizimpro), Pfizer Laboratories Div Pfizer Inc, effective June 23, 2026 (SPL set 4ab27d2f-e385-4e9c-b324-fa69c10b855a), via openFDA; the full label on DailyMed
What do FAERS reports show for dacomitinib?
The FDA Adverse Event Reporting System holds 746 reports that list dacomitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 329 are coded as a death and 212 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dacomitinib?
26 other medicines are given the same way (oral) and in the same FDA class as dacomitinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Crizotinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Entrectinib | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as dacomitinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dacomitinib
- 26 medicines for the same use
- Dacomitinib side effects
- the label's list beside FAERS reports
- Dacomitinib shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other