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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
Trade Name:  REBETOL
Date Designated:  04/04/2003
Orphan Designation:  Treatment of chronic hepatitis C in pediatric patients
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/29/2003 
Approved Labeled Indication:  Treatment of chronic hepatitis C among previously untreated pediatric patients at least three years of age or older.
Exclusivity End Date:    07/29/2010 
Exclusivity Protected Indication* :  
Schering Corporation
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
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.