Analysts were surprised to hear that GlaxoSmithKline was handed a "not approvable" letter for the supplemental drug application for the 500/50 strength of Advair Diskus for patients with chronic obstructive pulmonary disease. The company expressed surprise as well.
"The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations," says the company's statement. "GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair 250/50 strength."
- check out the release [1] on the rejection
Related Articles:
Advair fails to hit goal in COPD trial. Report [2]
New research highlights dangers of bronchodilators. Report [3]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-gsk-receives-decision-fda-advair-500-50-copd
[2] http://www.fiercebiotech.com/story/advair-fails-to-hit-goal-in-copd-trial/2007-03-16
[3] http://www.fiercebiotech.com/story/new-research-highlights-dangers-of-bronchodilators/2006-06-06