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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
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.

Marketing approved:

1 Generic Name: ribavirin
Trade Name: REBETOL
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* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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