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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) injection
Trade Name: Norditropin
Date Designated: 07/10/1987
Orphan Designation: 1. Treatment of growth failure in children due to inadequate growth hormone secretion 2. Treatment of short stature associated with Turner's syndrome
Orphan Designation Status: Designated/Approved
Novo Nordisk Pharmaceuticals
100 Overlook Center
Suite 200
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: Somatropin (rDNA origin) injection
Trade Name: Norditropin
Marketing Approval Date: 06/20/2000
Approved Labeled Indication: Long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone.
Exclusivity End Date: N/A  
2 Generic Name: somapacitan-beco
Trade Name: Sogroya
Marketing Approval Date: 04/28/2023
Approved Labeled Indication: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH)
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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