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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 4-[[(1S)-1-(4, 8-Dichloro-1-oxo-2-phenyl-3-isoquinolyl) ethyl] amino]-8H- pyrido[2,3-d] pyrimidin-5-one]
Date Designated: 10/11/2022
Orphan Designation: Treatment of Peripheral T-Cell Lymphoma, Not Otherwise Specified
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Boryung Co., LTD
Boryung Bldg
Changgyeonggung-ro 136
Seoul, Jongno-gu #####
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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