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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: 07/24/2014
Orphan Designation: Treatment of systemic sclerosis
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer HealthCare Pharmaceuticals, Inc.
100 Bayer Blvd
P. O. Box 915
Whippany, 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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