Advair 500/50 sNDA “not approvable”
Executive Summary
GlaxoSmithKline's sNDA for Advair Diskus (fluticasone/salmeterol inhalation powder) 500/50 mcg is "not approvable" for an expanded chronic obstructive pulmonary disease indication. In an Aug. 6 letter, FDA questions how the higher-dosing form of the long-acting beta agonist bronchodilator compares with the approved Advair 250/50 mcg strength. GSK does not have head-to-head data comparing the two formulations, the firm tells "The Pink Sheet." FDA's Pulmonary-Allergy Drugs Advisory Committee issued a mixed review of the product May 1, voting 9-2 that GSK's pivotal trial failed to provide "substantial convincing evidence" that the 500/50 dose increased COPD survival (1"The Pink Sheet" May 7, 2007, p. 12)...