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Myalept Approval History

FDA Approved: Yes (First approved February 24, 2014)
Brand name: Myalept
Generic name: metreleptin
Dosage form: Injection
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.

Development History and FDA Approval Process 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

Further information

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