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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Nintedanib
Date Designated:  12/12/2016
Orphan Designation:  Treatment of mesothelioma
Orphan Designation Status:  Designated
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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