Sanofi gets tentative FDA approval for Humalog follow-on Admelog

SILVER SPRING, Md. — The Food and Drug Administration recently granted tentative approval to Sanofi’s Admelog (insulin lispro injection, 100 units/ml), a rapid-acting human insulin analog. The drug, a follow-on biologic version of Lilly’s Humalog, is indicated to improve glycemic control in patients with diabetes. 

 

The approval means that Admelog has met all requirements for the regulatory agency, pending any patent issues that have not yet been resolved. 

 

"Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," SVP and head of Sanofi’s global diabetes franchise Stefan Oelrich said. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin."