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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (R)-(3-(2'-cyclopropyl-3-(hydroxymethyl)-[1,1'-biphenyl]-4-yl) pyrrolidin-1-yl)(5-fluoropyridin-2-yl)methanone
Date Designated: 08/06/2024
Orphan Designation: treatment of pachyonychia congenita
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kamari Pharma Ltd.
Pinchas Sapir 3
Science Park
Ness Ziona
Israel

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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