dacomitinib

FDA Drug Profile — Vizimpro

Drug Details

Generic Name
dacomitinib
Brand Names
Vizimpro
Application Number
NDA211288
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
4
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DACOMITINIB

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 )