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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Somatrem for injection
Trade Name: Protropin
Date Designated: 12/09/1985
Orphan Designation: 1. Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion (prevalence 15,000) 2. Treatment of short stature associated with Turner's syndrome (prevalence 8000).
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
Genentech, Inc.
460 Point San Bruno Boulevard
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: Somatrem for injection
Trade Name: Protropin
Marketing Approval Date: 10/17/1985
Approved Labeled Indication:
Exclusivity End Date: 10/17/1992 
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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