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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: decitabine
Trade Name: Dacogen
Date Designated: 03/08/1999
Orphan Designation: Treatment of myelodysplastic syndromes.
Orphan Designation Status: Designated/Approved
Otsuka Pharmaceutical Development
and Commercialization, Inc.
508 Carnegie Center Drive
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: decitabine
Trade Name: Dacogen
Marketing Approval Date: 05/02/2006
Approved Labeled Indication: for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups
Exclusivity End Date: 05/02/2013 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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