FDA Accepts Sanofi’s NDA for Basal Insulin Toujeo

Sanofi reports the US Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL),an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency for EU countries on May 27, 2014.

With the FDA's acceptance of the NDA submission, Sanofi anticipates the regulatory decision for marketing authorization for Toujeo in the US in the first half of 2015.

Source: Sanofi

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