Healthcare company Sanof (EURONEXT:SAN) (NYSE:SNY) disclosed on Friday that it has received US Food and Drug Administration (FDA) tentative approval for Admelog (insulin lispro injection) 100 units/ml for the management of blood sugar in diabetic patients.

The company said Admelog, a rapid-acting human insulin analog, is indicated to improve glycemic control in adults and children with diabetes mellitus.

This US FDA tentative approval is based on the company's physicochemical, non-clinical and clinical similarity to another insulin lispro 100 units/ml as currently approved in the US, including data from a clinical development programme involving more than 1,000 adults living with type 1 or type 2 diabetes.

Following the tentative approval, the US FDA concluded that the company's Admelog met all necessary regulatory requirements for approval in the US, pending any patent issues that are yet to be resolved.

Additionally, the trade name "Admelog" was granted provisional approval by the US FDA and will be used in the US when the product is made available. Admelog was granted marketing authorisation under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017, concluded the company.