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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Gonadorelin acetate
Trade Name: Lutrepulse
Date Designated: 04/22/1987
Orphan Designation: For induction of ovulation in women with hypothalamic amenorrhea due to a deficiency or absence in the quantity or pulse pattern of endogenous GnRH secretion.
Orphan Designation Status: Designated/Approved
Ferring Laboratories, Inc.
400 Rella Boulevard, Suite 201
Suffern, New York 10901
United States

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

Marketing approved:

1 Generic Name: Gonadorelin acetate
Trade Name: Lutrepulse
Marketing Approval Date: 10/10/1989
Approved Labeled Indication:
Exclusivity End Date: 10/10/1996 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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