19 August 2016 - Sanofi announced today that it has submitted updated information on the pen delivery device as part of the new drug application for the investigational once-daily fixed-ratio combination of basal insulin glargine 100 units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes mellitus.
The additional information, submitted at FDA’s request, constitutes a major mendment to the application, resulting in an extension of the Prescription Drug User Fee Act goal date by three months, to November 2016.