BioCentury
ARTICLE | Clinical News

Tresiba insulin degludec regulatory update

September 10, 2012 7:00 AM UTC

Novo Nordisk said the First Committee on Drugs of Japan's Pharmaceutical Affairs issued a positive recommendation on a marketing application for insulin degludec to treat Type I and Type II diabetes. Novo expects Japan's Ministry of Health, Labor and Welfare (MHLW) to make a decision "within a few months." Insulin degludec is a long-acting insulin analog. The product is also under review in the U.S., Europe, Canada and Switzerland. ...