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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Iloprost inhalation solution
Trade Name: Ventavis
Date Designated: 08/17/2004
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Approved
CoTherix, Inc.
5000 Shoreline Court
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Iloprost inhalation solution
Trade Name: Ventavis
Marketing Approval Date: 12/29/2004
Approved Labeled Indication: Treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms
Exclusivity End Date: 12/29/2011 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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