Exubera NDA Filed, But Inhaled Insulin Safety Issues May Complicate Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer and Sanofi-Aventis submit Exubera NDA March 1; the first inhaled insulin to reach FDA could see approval by early 2006 based on a standard 10-month review. The companies expected to submit an NDA in 2001, but were delayed by pulmonary safety questions