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Supprelin-LA FDA Approval History

FDA Approved: Yes (First approved May 3, 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 timeline 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

Further information

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