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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Melphalan
Trade Name: Alkeran For Injection
Date Designated: 02/24/1992
Orphan Designation: Treatment of patients with multiple myeloma for whom oral therapy is inappropriate.
Orphan Designation Status: Designated/Approved
Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park, North Carolina 27709
United States

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

Marketing approved:

1 Generic Name: Melphalan
Trade Name: Alkeran For Injection
Marketing Approval Date: 11/18/1992
Approved Labeled Indication: For the palliative treatment of patients with multiple myeloma for whom oral melphalan is not appropriate.
Exclusivity End Date: 11/18/1999 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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