U.S. FDA: Tentative Approval to Sanofi for Admelog (Insulin lispro injection) 100 units/ml

U.S. FDA has granted tentative approval for Admelog as announced by Sanofi. Admelog (insulin lispro injection) is rapid-acting human insulin analog. Admelog has the capability to improve the glycemic control in adults and children suffering from diabetes mellitus.

Sanofi received this tentative approval based on the physicochemical, nonclinical and clinical similarity to another insulin lispro. The insulin lispro is currently approved in U.S. including data from a clinical development program that involves more than 1000 adults. The participants involved are mainly the patients living with type 1 and type 2 diabetes.

Admelog is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients. With this tentative approval from FDA, it is clear that the Admelog met all necessary regulatory requirements for approval in U.S.

Stefan Oelrich, Senior Vice President and Head, Global Diabetes Franchise, Sanofi said, “Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar. With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin.”

The trade name “Admelog” has received the provisional approval by FDA and will be used in U.S. as and when the product is available in the market.  Admelong was also granted marketing authorization under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017.

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