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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Follitropin alfa, recombinant
Trade Name: Gonal-F
Date Designated: 12/21/1998
Orphan Designation: For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with pr
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: Follitropin alfa, recombinant
Trade Name: Gonal-F
Marketing Approval Date: 05/24/2000
Approved Labeled Indication: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Exclusivity End Date: 05/24/2007 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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