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Supprelin-LA Approval History

  • FDA approved: Yes (First approved May 3rd, 2007)
  • Brand name: Supprelin-LA
  • Generic name: histrelin acetate
  • Dosage form: Subcutaneous Implant
  • Company: Indevus Pharmaceuticals, Inc.
  • Treatment for: Precocious Puberty

Supprelin-LA is a once-yearly implant of the gonadotropin releasing hormone (GnRH) analog histrelin, indicated for the treatment of central precocious puberty (CPP), the premature onset of puberty in children.

Development History and FDA Approval Process for Supprelin-LA

May  4, 2007Approval Indevus Announces FDA Approval of Supprelin-LA
Sep  7, 2006Valera Pharmaceuticals Receives PDUFA Date for Supprelin-LA
Jul  6, 2006Valera Pharmaceuticals Submits NDA for Supprelin-LA

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