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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: beraprost sodium 314d
Date Designated: 12/22/2011
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/17/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lung Biotechnology PBC
1040 Spring Street
Silver Spring, Maryland 20910
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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