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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Jaktinib Dihydrochloride Monohydrate
Date Designated: 12/14/2020
Orphan Designation: Treatment of Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Suzhou Zelgen Biopharmaceuticals Co., Ltd.
No. 209, Chenfeng Road
Kunshan
Suzhou, Jiangsu Province 215300
China

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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