Glaxo Wellcome Advair

Executive Summary

Commercial introduction is a year away, the company predicted, although the product is coming up on milestones in its FDA review. The salmeterol/fluticasone combination is up for review by an FDA advisory committee Nov. 23 and the user fee review deadline could be as early as January based on the March 1999 NDA submission date. Another important new formulation for Glaxo's asthma product line, the chlorofluorocarbon-free formulation of albuterol (Ventolin HFA) is also in a temporary delay at FDA. The product was deemed "approvable" July 1