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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (6S,9aS)-N-benzyl-6-(4-hydroxybenzyl)-4,7-dioxo-2-((3-(pyridin-2-yl)isoxazol-5-yl)methyl)-8-(quinolin-5-ylmethyl)hexahydro-2H-pyrazino[2,1-c][1,2,4]triazine-1(6H)-carboxamide methane sulfonic acid
Date Designated: 06/07/2022
Orphan Designation: Treatment of Idiopathic Pulmonary Fribrosis (IPF)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
3Plus2 Pharma, LLC
3904 Chapman Ct.
Altadena, California 91001
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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