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FDA grants tentative approval to Sanofi for insulin lispro injection

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The FDA tentatively approved Admelog, Sanofi’s version of insulin lispro, a rapid-acting human insulin analogue, to improve glycemic control in adults and children with diabetes, according to a press release from Sanofi.

The tentative approval for the insulin lispro injection 100 units/mL is based on physiochemical, nonclinical and clinical similarity to another insulin lispro (Humalog, Eli Lilly) currently approved in the United States, according to the release.

All necessary regulatory requirements were met, but patent issues are pending before full approval can be granted by the FDA. The European Commission granted marketing authorization to Sanofi in July.

“Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar,” Stefan Oelrich, senior vice president and health, Global Diabetes Franchise at Sanofi, said in the release. “With this tentative approval, we are not one step closer to offering Admelog as an option for those who use rapid-acting insulin.”