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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Growth hormone releasing factor
Date Designated: 08/07/1989
Orphan Designation: For the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Valeant Pharmaceuticals North America
700 Route 202/206
Bridgewater, New Jersey 08807
United States

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

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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