Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
For congenital or acquired generalized lipodystrophy. Sold as Myalept. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Metreleptin (sold as Myalept), first approved Feb 24, 2014, with 0 new uses approved and 0 published complete response letters.
First approved: Feb 24, 2014
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $29.7M
First approved in the EU: Jul 30, 2018
First approved in Japan: Mar 25, 2013
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
