The U.S. Food and Drug Administration approved Sanofi's 100 units/milliliters dose of Admelog.
Admelog is a rapid-acting insulin similar to Eli Lilly and Co.'s Humalog, another insulin lispro 100 units/mL, currently approved in the U.S.
The clinical development program of Admelog, or insulin lispro injection — a follow-on mealtime insulin — involved more than 1,000 adults with type 1 or type 2 diabetes.
Sanofi said Admelog will be available in both vials and the SoloStar pen.
In September, the U.S. regulator granted a tentative approval to Admelog.
Admelog was also granted marketing authorization as a biosimilar, under the name Insulin lispro Sanofi, by the European Commission in July.
