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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 oral suspension
Trade Name: Tiglutik
Date Designated: 09/15/2016
Orphan Designation: Treatment of amyotrophic lateral sclerosis (ALS).
Orphan Designation Status: Designated/Approved
Italfarmaco SpA
54 Via dei Lavoratori
Cinisello Balsamo, Lombardia 20092
Italy

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

Marketing approved:

1 Generic Name: riluzole oral suspension
Trade Name: Tiglutik
Marketing Approval Date: 09/05/2018
Approved Labeled Indication: TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Exclusivity End Date: N/A  
2 Generic Name: riluzole oral suspension
Trade Name: Tiglutik
Marketing Approval Date: 12/13/2019
Approved Labeled Indication: TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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