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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: 3-Acetyl-1-cyclopentyl-7-{[(3S,4R)-3-hydroxyoxan-4-yl]amino }-4-methyl-1,6-naphthyridin-2(1H)-one
Date Designated: 02/18/2021
Orphan Designation: Treatment of pulmonary arterial hypertension
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/22/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pfizer, Inc.
235 East 42nd Street
New York, New York 10017
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.