FDA Approves Eli Lilly’s Humulin R U-500 KwikPen

Eli Lilly and Co. Jan. 21 said the FDA has approved its insulin product Humulin R U-500 KwikPen (insulin human injection) 500 units/milliliter.

Humulin R U-500 is the only Food and Drug Administration-approved insulin that is five times more concentrated than standard U-100 insulin, the Indianapolis-based company said. This insulin is used to treat high blood sugar in people with type 1 and type 2 diabetes who need more than 200 units of insulin per day.

Eli Lilly said the safety and efficacy of Humulin R U-500 used in combination with other insulins or delivered by an insulin infusion pump ...