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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)-1-[4'-(5-chloro-3-{[(1-phenylethoxy)carbonyl] amino}thiophen-2-yl)-2'-methoxy-[1,1'-biphenyl]-4-yl]cyclopropanecarboxylic acid
Date Designated: 06/12/2023
Orphan Designation: Treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
HiLung, Inc.
46-29 Yoshida-Shimo'adachicho, Sakyo-ku
Kyoto, Kansai 00000
Japan

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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