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FDA: Tentative OK for Admelog
FDA officials noted that the human insulin analog met all necessary regulatory requirements for approval, but the approval is tentative pending any patent issues that are yet to be resolved.
Officials with Sanofi announced today in a press release that the US FDA has granted tentative approval for their human insulin analog (Admelog) 100 Units/mL, which is indicated to improve glycemic control in adults and children with diabetes mellitus.
The release noted that the tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL, and data from a clinical development program that involved 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.
FDA officials noted that the human insulin analog met all necessary regulatory requirements for approval, but the approval is tentative pending any patent issues that are yet to be resolved.
For more on what pharmacists can advise patients with diabetes, view the video below:
