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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: omacetaxine mepesuccinate
Trade Name: Synribo
Date Designated: 03/10/2006
Orphan Designation: Treatment of chronic myelogenous leukemia
Orphan Designation Status: Designated/Approved
IVAX International GmbH
Alpenstrasse 2
8640 Rapperswil
Frazer
Switzerland

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

Marketing approved:

1 Generic Name: omacetaxine mepesuccinate
Trade Name: Synribo
Marketing Approval Date: 10/26/2012
Approved Labeled Indication: Treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI)
Exclusivity End Date: 10/26/2019 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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