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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 5-((4-(6-chlorothieno[2,3-d]pyrimidine-4-ylamino)piperidin-1-yl)methyl)-2-fluorobenzonitrile monofumurate
Date Designated: 10/21/2010
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Forest Laboratories, Inc.
Harborside Financial Center
Plaza V
Jersey City, New Jersey 07311
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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