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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Nafarelin acetate
Trade Name: Synarel Nasal Solution
Date Designated: 07/20/1988
Orphan Designation: Treatment of central precocious puberty.
Orphan Designation Status: Designated/Approved
Syntex (USA), Inc.
3401 Hillview Avenue
Palo Alto, California 94303
United States

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

Marketing approved:

1 Generic Name: Nafarelin acetate
Trade Name: Synarel Nasal Solution
Marketing Approval Date: 02/26/1992
Approved Labeled Indication: Treatment of central precocious puberty (gonadotropin-dependent precocious puberty) in children of both sexes.
Exclusivity End Date: 02/26/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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