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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sodium phenylbutyrate and taurursodiol
Trade Name: Relyvrio
Date Designated: 07/27/2017
Orphan Designation: Treatment of amyotrophic lateral sclerosis (ALS)
Orphan Designation Status: Designated/Approved
Amylyx Pharmaceuticals, Inc.
43 Thorndike St.
Cambridge, Massachusetts 02141
United States

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

Marketing approved:

1 Generic Name: sodium phenylbutyrate and taurursodiol
Trade Name: Relyvrio
Marketing Approval Date: 09/29/2022
Approved Labeled Indication: Treatment of amyotrophic lateral sclerosis (ALS) in adults
Exclusivity End Date: 09/29/2029 
Exclusivity Protected Indication* :  Treatment of amyotrophic lateral sclerosis (ALS) in adults
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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