FDA Grants Tentative Approval for Admelog (Insulin Lispro Injection)

September, 2017

September 1, 2017. The U.S. Food and Drug Administration (FDA) has granted tentative approval to Sanofi for a rapid-acting human insulin analog called Admelog (insulin lispro injection) 100 units/mL, indicated to improve glycemic control in adults and children with diabetes. Tentative approval was granted because Admelog is similar to FDA-approved insulin lispro injection in its physiochemical, nonclinical, and clinical characteristics. Admelog is contraindicated in patients with hypersensitivity to insulin lispro or any of its ingredients; it is also contraindicated during episodes of hypoglycemia. More information is available here.