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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: treprostinil sodium solution enclosed within a pre-filled, pre-programmed, single-use, electronically-controlled infusion pump
Date Designated: 12/29/2015
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SteadyMed Therapeutics
2603 Camino Ramon
Suite 350
San Ramon, California 94583
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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