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GLP-1RA, Topics

June 16, 2017

LEADER FDA Briefing Documents Released

Here is a brief preview of this blast: The briefing documents for the June 20, 2017 LEADER adcom were posted by the FDA. Recall, Novo Nordisk submitted the sNDA efficacy supplement for Victoza (liraglutide 1.8 mg) on October 25, 2016, which suggests the PDUFA date will be on or around August 25 following a 10-month review.