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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  cedazuridine and decitabine
Trade Name:  Inqovi
Date Designated:  08/21/2019
Orphan Designation:  Treatment of myelodysplastic syndromes (including chronic myelomonocytic leukemia)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  07/07/2020 
Approved Labeled Indication:  Indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Exclusivity End Date:    07/07/2027 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Astex Pharmaceuticals, Inc.
4420 Rosewood Drive
Suite 200
Pleasanton, California 94588
United States

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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