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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: deflazacort
Date Designated: 10/22/2015
Orphan Designation: Treatment of pediatric (0 through 16 years of age) juvenile idiopathis arthritis (JIA) International League of Associations for Rheumatology (ILAR) categories excluding systemic JIA.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 11/22/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield, New Jersey 07080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.