The rapid-acting insulin received tentative approval based on its similarity to Eli Lilly's Humalog.
Sanofi announced Friday that FDA has granted tentative approval for its rapid-acting insulin lispro injection 100 units/mL, which will have the trade name Admelog if the drug becomes available.
The tentative approval is based on physicochemical, nonclinical and clinical similarity to Eli Lilly’s Humalog. The European Commission approved the product in July under the trade name Insulin lispro Sanofi.
Rapid-acting insulin is taken at mealtime. FDA tentative approval is based on a development program involving adults with type 1 and type 2 diabetes. Tentative approval means the data in the marketing application were complete to qualify for approval, but that there are unresolved patent issues.
"Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," Stefan Oelrich, senior vice president and head, Global Diabetes Franchise, Sanofi, said in a statement. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin."