Posted by Michael Wonder on 11 Dec 2017
FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes
11 December 2017 - The U.S. FDA today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and paediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.
Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway).
Admelog received tentative approval from the FDA on 1 September 2017 and is now being granted final approval.
The approval of Admelog was granted to Sanofi-Aventis.
