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Generic Name: Sermorelin acetate Date Designated: 02/13/1990 Orphan Designation: Adjunct to gonadotropin therapy in the induction of ovulation in women with anovulatory or oligo-ovulatory infertility who fail to ovulate in response to adequate treatment with clomiphene citrate alone and gonadotropin therapy alone. Orphan Designation Status: Designated/Designation Withdrawn or Revoked FDA Orphan Approval Status: Not FDA Approved for Orphan Indication Sponsor: EMD Serono, Inc. One Technology Place Rockland, Massachusetts 02370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.
*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 *Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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