Sanofi Withdrawing NDA for Lixisenatide
Sanofi announced they are withdrawing their New Drug Application (NDA) for their once-daily GLP-1 lixisenatide from the FDA. The combination of lixisenatide and Lantus® (basal insulin), the investigational LixiLan fixed-ratio product, remains on schedule to enter into phase 3 in the first half of 2014.
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