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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 [rDNA]
Trade Name: Genotropin
Date Designated: 12/27/2000
Orphan Designation: Treatment of growth failure in children who were born small for gestational age.
Orphan Designation Status: Designated/Approved
Pharmacia and Upjohn Company
7000 Portage Road
Kalamazoo, Michigan 49001
United States

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

Marketing approved:

1 Generic Name: somatropin [rDNA]
Trade Name: Genotropin
Marketing Approval Date: 07/25/2001
Approved Labeled Indication: For long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age.
Exclusivity End Date: 07/25/2008 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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