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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant human luteinizing hormone
Trade Name: Luveris
Date Designated: 10/07/1994
Orphan Designation: For use in association with recombinant human follicle stimulating hormone for the treatment of women with chronic anovulation due to hypogonadotropic hypogonadism.
Orphan Designation Status: Designated/Approved
EMD Serono, Inc.
One Technology Place
Rockland, Massachusetts 02370
United States

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

Marketing approved:

1 Generic Name: Recombinant human luteinizing hormone
Trade Name: Luveris
Marketing Approval Date: 10/08/2004
Approved Labeled Indication: Luveris (lutropin alfa for injection), concomitantly administered with Gonal-f (follitropin alfa for injection), is indicated for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH (less than) 1.2 IU/L).
Exclusivity End Date: 10/08/2011 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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