Supprelin-LA Approval History
- FDA approved: Yes (First approved May 3rd, 2007)
- Brand name: Supprelin-LA
- Generic name: histrelin acetate
- 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, 2007||Indevus Announces FDA Approval of Supprelin-LA|
|Sep 7, 2006||Valera Pharmaceuticals Receives PDUFA Date for Supprelin-LA|
|Jul 6, 2006||Valera Pharmaceuticals Submits NDA for Supprelin-LA|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.