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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: dacomitinib
Trade Name: VIZIMPRO
Date Designated: 03/03/2015
Orphan Designation: Treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations.
Orphan Designation Status: Designated/Approved
Pfizer, Inc.
66 Hudson Boulevard East
New York, New York 10001
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: dacomitinib
Trade Name: VIZIMPRO
Marketing Approval Date: 09/27/2018
Approved Labeled Indication: 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
Exclusivity End Date: 09/27/2025 
Exclusivity Protected Indication* :  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
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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