Search Orphan Drug Designations and Approvals
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Generic Name: | Riluzole | ||||||||||||||||
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Trade Name: | Rilutek | ||||||||||||||||
Date Designated: | 03/16/1993 | ||||||||||||||||
Orphan Designation: | Treatment of amyotrophic lateral sclerosis. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Riluzole |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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