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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: riociguat
Date Designated: 06/26/2019
Orphan Designation: Treatment of Fontan-palliated patients
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer U.S. LLC
100 Bayer Boulevard
P.O. Box 915
Hanover, New Jersey 07981
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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