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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
Date Designated: 09/01/1987
Orphan Designation: Adjunct for the induction of ovulation in women with infertility due to hypogonadotropic hypogonadism or bilateral tubal occlusion or unexplained infertility, who are undergoing in vivo or in vitro fertilization procedures.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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