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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: solnatide
Date Designated: 02/08/2016
Orphan Designation: Treatment of generalized systemic pseudohypoaldosteronism type 1 (also known as autosomal recessive PHA-I or PHA-IB)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Apeptico Forschung und Entwicklung GmbH (APEPTICO)
Mariahilferstrabe 136
Top 1150
Vienna
Austria

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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