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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 Sponsor: 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 *Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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