The Food and Drug Administration (FDA) has granted tentative approval for Basaglar (insulin glargine injection; Boehringer Ingelheim and Lilly) to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.

Basaglar contains the same amino acid sequence as the currently available insulin glargine product, and has been tentatively approved for use with the prefilled dosing device, KwikPen.

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The tentative approval indicates that the FDA has determined Basaglar meets all the regulatory requirements for approval but it is subject to a stay of up to 30 months due to a litigation filed by Sanofi claiming patent infringement. The final FDA approval has to come at the end of the 30-month period in mid-2016 unless the court finds Lilly in favor earlier.

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