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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: repository corticotropin or adrenocorticotropic hormone
Trade Name: H.P. Acthar Gel
Date Designated: 05/21/2003
Orphan Designation: Treatment of infantile spasms
Orphan Designation Status: Designated/Approved
Questcor Pharmaceuticals, Inc.
26118 Research Road
Hayward, California 94545
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: repository corticotropin or adrenocorticotropic hormone
Trade Name: H.P. Acthar Gel
Marketing Approval Date: 10/15/2010
Approved Labeled Indication: To treat infantile spasms
Exclusivity End Date: 10/15/2017 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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