> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Panel Backs Sanofi Combination Product for Diabetics
- URL: https://www.fdaweb.com/panel-backs-sanofi-combination-product-for-diabetics/
- Published: 2016-05-26T12:00:00.000Z
- Updated: 2026-09-14T21:05:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135775

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 12 to 2 to recommend approval for a Sanofi NDA for iGlarLixi (insulin glargine and lixisenatide) injection and lixisenatide injection as monotherapy, indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Several panel members expressed concern with the pen administration device used to deliver the medications. Specifically, they were concerned that pen’s design was confusing and could lead to dosing errors. They urged the agency and the company to address these issues prior to approving the NDA.