Compliance Management

Sanofi-Aventis Wins FDA Approval for Follow-On Diabetes Drug

Dec 11, 2017

FDA approved Admelog, the first short-acting "follow-on" insulin to improve control in blood sugar levels for certain patients with type 1 and type 2 diabetes mellitus

The U.S. FDA approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. FDA says it is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” said FDA Commissioner Scott Gottlieb, M.D.

Admelog was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, called the 505(b)(2) pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.

Admelog received tentative approval from the FDA on Sept. 1, 2017, and is now being granted final approval.