Myalept Approval History

  • FDA approved: Yes (First approved February 24th, 2014)
  • Brand name: Myalept
  • Generic name: metreleptin
  • Company: Amylin Pharmaceuticals, Inc.
  • Treatment for: Lipodystrophy

Myalept (metreleptin) is a leptin analog indicated to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

FDA Approval History for Myalept

DateArticle
Feb 25, 2014Approval FDA Approves Myalept to Treat Generalized Lipodystrophy
Dec 12, 2013FDA Advisory Committee Votes on Investigational Medicine Metreleptin
Apr  3, 2012Amylin Completes Biologics License Application for Metreleptin to Treat Diabetes and/or Hypertriglyceridemia in Patients With Rare Forms of Lipodystrophy
Dec 20, 2010Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Application for Metreleptin to Treat Rare Forms of Lipodystrophy

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.

Hide
(web4)