FDAnews
www.fdanews.com/articles/84345-fda-approves-pfizer-s-exubera-for-diabetes

FDA APPROVES PFIZER'S EXUBERA FOR DIABETES

February 6, 2006

The FDA has approved Pfizer's inhaled insulin product Exubera for the treatment of adults with Type 1 and Type 2 diabetes.

The product, an inhaled form of recombinant human insulin, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s, the FDA said. Currently more than 5 million Americans take insulin injections to control diabetes, the agency said.

The U.S. approval of Exubera on Jan. 27 came one day after the European Commission approved the product in the EU. The FDA's move also follows a September 2005 recommendation of the agency's Endocrinologic and Metabolic Drugs Advisory Committee.