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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: N-[(2S)-1-[(3aS,6R,6aR)-6-Ethynyl-3-oxohexahydro-2H-furo[3,2-b]pyrrol-4-yl]-4-methyl-1-oxopentan-2-yl]-4-[5-fluoro-2-(4-methylpiperazin-1-yl)-1,3-thiazol-4-yl]benzamide hydrochloride
Date Designated: 04/15/2024
Orphan Designation: treatment of Legg-Calve-Perthes Disease (LCPD)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
OsteoCat Therapeutics AB
Lunastigen 5
Huddinge, Huddinge Se-141 22
Sweden

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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