Admelog Tentatively Approved for Diabetes Mellitus
The Food and Drug Administration (FDA) has granted tentative approval for Admelog (insulin lispro injection; Sanofi) 100 Units/mL to improve glycemic control in adults and children with diabetes mellitus.
Admelog, a rapid-acting human insulin analog, was tentatively approved based on its similarity to another approved insulin lispro product. Pending any patent issues that have yet to be resolved by the Company, the FDA has concluded that the product has met all necessary regulatory requirements for approval.
Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Admelog is contraindicated in patients during episodes of hypoglycemia and in patients who are hypersensitive to insulin lispro or to any of its excipients.
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