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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  vardenafil
Date Designated:  04/22/2019
Orphan Designation:  Treatment of Pulmonary Arterial Hypertension
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Respira Therapeutics, Inc
5901 Indian School Road NE
Albuquerque, New Mexico 87110
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.