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.

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments