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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Zamicastat
Date Designated: 07/15/2019
Orphan Designation: Treatment of pulmonary arterial hypertension (PAH) (pulmonary hypertension WHO Group 1)
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/22/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bial-Portela & Cª., S.A.
À Av. da Siderurgia Nacional
4745-457 S. Mamede do Coronado
Coronado
Portugal

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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