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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Riluzole
Trade Name: Rilutek
Date Designated: 03/16/1993
Orphan Designation: Treatment of amyotrophic lateral sclerosis.
Orphan Designation Status: Designated/Approved
Rhone-Poulenc Rorer Pharmaceuticals, Inc.
500 Arcola Road, P.O. Box 1200
Collegeville, Pennsylvania 19426
United States

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

Marketing approved:

1 Generic Name: Riluzole
Trade Name: Rilutek
Marketing Approval Date: 12/12/1995
Approved Labeled Indication: Treatment of patients with amyotrophic lateral sclerosis. Riluzole extends survival and/or time to tracheostomy.
Exclusivity End Date: 12/12/2002 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.