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Sanofi's iGlarLixi: Two Formulations Raise FDA Red Flag On Dosing Errors

 
• By Sue Sutter

Sponsor's plan to market two self-injectable pens with different fixed-ratio concentrations of insulin glargine and lixisenatide may result in patients getting inappropriate dose, FDA says in advisory committee briefing documents that also question clinical utility.

Sanofi's plan to market its fixed-ratio combination of Lantus (insulin glargine) and the GLP-1 agonist lixisenatide in two different pen presentations has raised FDA questions about medication error potential on top of concerns about the antidiabetic combination product's clinical utility.

"The agency has residual concerns with regard to the potential for errors, particularly given the proposal to market two different pen injectors with two different ratios of the components," FDA said in

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• By Sue Sutter

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