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 diabetes mellitus. Sold as Semglee. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Insulin Glargine-Yfgn (sold as Semglee), first approved Jul 28, 2021, with 0 new uses approved and 0 published complete response letters.
First approved: Jul 28, 2021
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $119M
First approved in the EU: Jun 9, 2000
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Lantus XR, new approvalA drug in a new dosage form indicated for the treatment of diabetes mellitus in cases where insulin therapy is indicated. · Sanofi K.K. · Jul 3, 2015
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
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
Mylan Pharms Inc