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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: afatinib
Trade Name: Gilotrif
Date Designated: 08/03/2015
Orphan Designation: Treatment of non-small cell lung cancer with squamous histology.
Orphan Designation Status: Designated/Approved
Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road
P. O. Box 368
Ridgefield, Connecticut 06877
United States

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

Marketing approved:

1 Generic Name: afatinib
Trade Name: Gilotrif
Marketing Approval Date: 04/15/2016
Approved Labeled Indication: Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
Exclusivity End Date: 04/15/2023 
Exclusivity Protected Indication* :  Treatment of patients with metastatic, squamous, non-small cell lung cancer progressing after platinum-based chemotherapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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