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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
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.

Marketing approved:

1 Generic Name: cedazuridine and decitabine
Trade Name: Inqovi
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.

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