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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Interferon beta-1b
Trade Name: Betaseron
Date Designated: 11/17/1988
Orphan Designation: Treatment of multiple sclerosis.
Orphan Designation Status: Designated/Approved
Chiron Corp. & Berlex Laboratories
4560 Horton Street
Emeryville, California 94608
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Interferon beta-1b
Trade Name: Betaseron
Marketing Approval Date: 07/23/1993
Approved Labeled Indication: In ambulatory patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations.
Exclusivity End Date: 07/23/2000 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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