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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  dexamethasone
Trade Name:  
Date Designated:  03/26/2018
Orphan Designation:  Treatment of multiple myeloma (MM)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/03/2019 
Approved Labeled Indication:  HEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma
Exclusivity End Date:    10/03/2026 
Exclusivity Protected Indication* :  Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM).
Dexcel Pharma Technologies Ltd
Dexcel Street
Or Akiva, Haifa District
Israel

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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