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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  ribavirin
Date Designated:  04/12/1991
Orphan Designation:  Treatment of hemorrhagic fever with renal syndrome
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Valeant Pharmaceuticals International
3300 Hyland Avenue
Costa Mesa, California 92626
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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