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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: edaravone
Trade Name: Radicava
Date Designated: 05/12/2015
Orphan Designation: Treatment of amyotrophic lateral sclerosis
Orphan Designation Status: Designated/Approved
Mitsubishi Tanabe Pharma Corporation
17-10, Nihonbashi-Koamicho
Tokyo
Japan

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

Marketing approved:

1 Generic Name: edaravone
Trade Name: Radicava
Marketing Approval Date: 05/05/2017
Approved Labeled Indication: Treatment of amyotrophic lateral sclerosis (ALS)
Exclusivity End Date: 05/05/2024 
Exclusivity Protected Indication* :  Treatment of amyotrophic lateral sclerosis (ALS)
2 Generic Name: edaravone
Trade Name: Radicava ORS
Marketing Approval Date: 05/12/2022
Approved Labeled Indication: Treatment of amyotrophic lateral sclerosis (ALS)
Exclusivity End Date: 05/12/2029 
Exclusivity Protected Indication* :  Treatment of amyotrophic lateral sclerosis (ALS)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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