May 2016 Endocrinologic and Metabolic Drugs Advisory Committee Meetings

Endocrinologic and Metabolic Drugs Advisory Committee (May 24)

The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. More information

Endocrinologic and Metabolic Drugs Advisory Committee (May 25)

The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus. More information

Helene Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network