Lilly gets tentative approval for diabetes drug

|By:, SA News Editor

The FDA grants tentative approval for Eli Lilly (LLY +0.5%) and Boehringer Ingelheim's Basaglar (insulin glargine injection) as a treatment to improve glycemic control in adults with type 2 diabetes and in combination with prandial insulin in adult and pediatric patients with type 1 diabetes.

While the FDA has determined that Basaglar meets all the criteria for market clearance, it is tentative because of the automatic 30-month stay due to Sanofi's (SNY -0.8%) patent infringement suit. The agency cannot issue final approval until the stay ends (mid-2016) or unless the court finds in Lilly's favor before then.