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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: 07/06/1999
Orphan Designation: Treatment of short stature in patients with Prader-Willi syndrome.
Orphan Designation Status: Designated/Approved
Pharmacia & Upjohn
7000 Portage Rd.
0633-298-113
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: 06/20/2000
Approved Labeled Indication: Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS).
Exclusivity End Date: 06/20/2007 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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