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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-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid
Date Designated: 12/23/2014
Orphan Designation: Prevention of acute attacks of angioedema in individuals with hereditary angioedema
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/22/2017
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd
Suite 200200
Durham, North Carolina 27703
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.