Sanofi provides update on new drug application for investigational once-daily fixed-ratio combination of insulin glargine and lixisenatide

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.

Read Sanofi press release

Michael Wonder

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Michael Wonder