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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: imetelstat
Trade Name: Rytelo
Date Designated: 12/23/2015
Orphan Designation: Treatment of myelodysplastic syndrome
Orphan Designation Status: Designated/Approved
Geron Corporation
919 E. Hillsdale Blvd., Suite 250
Foster City, California 94404
United States

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

Marketing approved:

1 Generic Name: imetelstat
Trade Name: Rytelo
Marketing Approval Date: 06/06/2024
Approved Labeled Indication: treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA)
Exclusivity End Date: 06/06/2031 
Exclusivity Protected Indication* :  treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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