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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Pegvisomant
Trade Name: Somavert
Date Designated: 06/24/1997
Orphan Designation: Treatment of acromegaly.
Orphan Designation Status: Designated/Approved
Sensus Corporation
Suite 430,
98 San Jacinto Boulevard
Austin, Texas 78701
United States

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

Marketing approved:

1 Generic Name: Pegvisomant
Trade Name: Somavert
Marketing Approval Date: 03/25/2003
Approved Labeled Indication: Treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate
Exclusivity End Date: 03/25/2010 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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