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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
Trade Name:  OFEV
Date Designated:  07/06/2016
Orphan Designation:  Treatment of systemic sclerosis (including the associated interstitial lung disease).
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  09/06/2019 
Approved Labeled Indication:   OFEV is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).
Exclusivity End Date:    09/06/2026 
Exclusivity Protected Indication* :  Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
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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