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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Somatropin (r-DNA)
Trade Name: Zorbtive
Date Designated: 03/06/1995
Orphan Designation: For use alone or in combination with glutamine in the treatment of short bowel syndrome.
Orphan Designation Status: Designated/Approved
EMD Serono, Inc.
One Technology Place
Rockland, Massachusetts 02370
United States

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

Marketing approved:

1 Generic Name: Somatropin (r-DNA)
Trade Name: Zorbtive
Marketing Approval Date: 12/01/2003
Approved Labeled Indication: Treatment of short bowel syndrome in patients receiving specialized nutritional support
Exclusivity End Date: 12/01/2010 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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