FDA gives tentative approval for Admelog (insulin lispro injection) for glycemic control in adults and children with diabetes.-Sanofi.
The FDA has granted tentative approval for Admelog (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog, from Sanofi. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus. The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the U.S., including data from a clinical development program involving more than 1,000 adults living with type 1 or 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 the tentative approval, the FDA concluded that Admelog met all necessary regulatory requirements for approval in the U.S., pending any patent issues that are yet to be resolved.
Comment: Admelog was also granted marketing authorization under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017.
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