Drug Update: December 2016 Issue 2

New Drug Launch

Follow-On Product to Lantus® Launched: Basaglar®

Last December, the U.S. Food and Drug Administration (FDA) approved the first “follow-on” insulin glargine product, Basaglar® (insulin glargine injection). However, due to patent ligitation, Basaglar was not released to the U.S. market until December 15, 2016. Basaglar is a copycat of Sanofi-Aventis’ long-acting insulin product Lantus® (insulin glargine injection) and is indicated for improving blood glucose control in adult and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. Read more

Drug Update: December 2016 Issue 1

New Drug Approvals

FDA Approves Two New Combination Products for Type 2 Diabetes

Last month, the U.S. Food and Drug Administration (FDA) approved two new combination fixed dose diabetes medications each containing a glucagon-like peptide 1 (GLP-1) receptor agonist and a long-acting insulin: Xultophy® (insulin degludec/liraglutide) and Soliqua® (insulin glargine/lixisenatide). Both medications are indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes not adequately controlled on basal insulin or a GLP-1 agonist alone. Earlier this year, advisory committees to the FDA voted in favor of approval of both agents, however the FDA delayed a decision regarding approval of the products for 3 months. Read more