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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Sermorelin acetate
Trade Name: Geref
Date Designated: 09/14/1988
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: Sermorelin acetate
Trade Name: Geref
Marketing Approval Date: 09/26/1997
Approved Labeled Indication:
Exclusivity End Date: 09/26/2004 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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