How did this difference in approved doses come about? It may be helpful to review the dose-ranging study that led Novartis AG to select 150 or 300 μg as its dosage for subsequent phase 3 development. To select the optimal dosage, a population of patients with COPD was randomized to one of four doses of indacaterol (75, 150, 300, or 600 μg/d), placebo, or one of two active comparators—formoterol or tiotropium. An independent committee reviewed clinical trial results and, focusing on spirometric outcomes with trough FEV1 being paramount, the committee selected the optimal dose of indacaterol. The committee used as its criterion superiority to the active comparators, formoterol and tiotropium. While this has obvious commercial implications, it is also a reasonable criterion for the practicing clinician. COPD is, by definition, a disease of unmet needs; addressing these abnormalities with more effective therapy than currently available would be desirable. Subsequent phase 3 trials with indacaterol used either or both indacaterol 150 μg/d or indacaterol 300 μg/d. When the FDA committee reviewed this approach to dose selection, it preferred a different benchmark—the lowest dose that would provide a 24-h bronchodilator effect.2 The stated rationale was a concern that there were dose-related adverse effects to be expected from the use of LABAs.