FDA requiring LABA safety trials

FDA ordered four pharmas to conduct postmarketing trials to evaluate the safety of their respective long-acting beta agonist drugs with or without inhaled corticosteroids to treat asthma. The decision follows an FDA advisory committee meeting last year that voted randomized controlled trials would best evaluate serious asthma outcomes with marketed LABAs when added to corticosteroids (see BioCentury, March 22, 2010). ...