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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 for injection
Trade Name: Humatrope
Date Designated: 06/12/1986
Orphan Designation: For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.
Orphan Designation Status: Designated/Approved
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
United States

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

Marketing approved:

1 Generic Name: Somatropin for injection
Trade Name: Humatrope
Marketing Approval Date: 03/08/1987
Approved Labeled Indication:
Exclusivity End Date: 03/08/1994 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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