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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: methylene blue0.5%
Trade Name: ProvayBlue
Date Designated: 12/18/2012
Orphan Designation: Treatment of hereditary and acquired methemoglobinemia
Orphan Designation Status: Designated/Approved
Provepharm SAS
Technopote de Chateau-Combert
Marseille
France

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

Marketing approved:

1 Generic Name: methylene blue0.5%
Trade Name: ProvayBlue
Marketing Approval Date: 04/08/2016
Approved Labeled Indication: For treatment of pediatric and adult patients with acquired methemoglobinemia.
Exclusivity End Date: 04/08/2023 
Exclusivity Protected Indication* :  For treatment of pediatric and adult patients with acquired methemoglobinemia.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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