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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)-2-(5-cyano-2-(6-(methoxycarbonyl)-7-methyl-3-oxo-8-(3-(trifluoromethyl)phenyl)-2,3,5,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrimidin-5-yl)phenyl)-N,N,N-trimethylethanaminium methanesulfonate dehydrate
Date Designated: 01/25/2017
Orphan Designation: Treatment of cystic fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Chiesi Farmaceutici S.p.A.
26A Via Palermo
Parma, Emilia-Romagna
Italy

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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