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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 3-(6-(1-(2,2-difluorobenzo[d] [1,3]dioxyl-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Date Designated: 03/02/2010
Orphan Designation: Treatment of cystic fibrosis
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 06/09/2017
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Vertex Pharmaceuticals Inc.
130 Waverly Street
Cambridge, Massachusetts 02139
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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