Search Orphan Drug Designations and Approvals
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Generic Name: | Zamicastat |
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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Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
Date Designation Withdrawn or Revoked: | 09/22/2022 |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 |
Sponsor: |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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