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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: Saizen
Date Designated: 03/06/1987
Orphan Designation: Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.
Orphan Designation Status: Designated/Approved
EMD Serono, Inc.
One Technology Place
Rockland, Massachusetts 02370
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: Saizen
Marketing Approval Date: 10/08/1996
Approved Labeled Indication: Long term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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