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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-1a
Trade Name: Avonex
Date Designated: 12/16/1991
Orphan Designation: Treatment of multiple sclerosis.
Orphan Designation Status: Designated/Approved
Biogen, Inc.
14 Cambridge Center
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: Interferon beta-1a
Trade Name: Avonex
Marketing Approval Date: 05/17/1996
Approved Labeled Indication: Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.
Exclusivity End Date: 05/17/2003 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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