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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
Date Designated: 06/04/2014
Orphan Designation: Treatment of malignant brain and central nervous system tumors
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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