11 June 2020 - FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions of Americans living with diabetes.
Mylan and Biocon today announced that the U.S. FDA has approved the new drug application for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.
Semglee has an identical amino acid sequence to Sanofi's Lantus and is approved for the same indications.