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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 origin)
Trade Name: Nutropin Depot
Date Designated: 10/28/1999
Orphan Designation: Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: Somatropin (rDNA origin)
Trade Name: Nutropin Depot
Marketing Approval Date: 12/22/1999
Approved Labeled Indication: Long-term treatment of growth failure due to a lack of adequate endogenous growth hormone secetion for once- or twice-a-month administration.
Exclusivity End Date: N/A  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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