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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
Dexcel Pharma Technologies Ltd
Dexcel Street
Or Akiva, Haifa District
Israel

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

Marketing approved:

1 Generic Name: dexamethasone
Trade Name:
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).

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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