FDA Makes It Official With Basaglar Approval For Diabetes

Eli Lilly/Boehringer Ingelheim’s insulin glargine product had already received tentative approval from FDA. The final approval clears the way for an eventual copycat version of Sanofi’s Lantus.

FDA approved Eli Lilly & Co./Boehringer Ingelheim GMBH’s copycat version of Sanofi’s Lantus (insulin glargine) Dec. 16, paving the way for a launch as anticipated in December 2016. FDA approved the long-acting insulin, Basaglar (insulin glargine), in adult and pediatric patients with type 1 and type 2 diabetes.

The approval follows the tentative approval granted for Lilly/BI’s NDA for Basaglar in August 2014 ([A#14140819002]). The tentative approval...

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