Search Orphan Drug Designations and Approvals
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Generic Name: | Urofollitropin |
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Date Designated: | 12/05/1997 |
Orphan Designation: | For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
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. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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