Forest Aerobid promotions

Executive Summary

FDA April 20 notice of violation letter cites Aerobid/Aerobid-M inhaler promotions for implied safety claims. The agency says the tagline "Potency where you want it" with and without accompanying lung graphic is "an implied safety claim because it suggests that the clinical response from this orally inhaled corticosteroid is only due to direct local effect rather than an indirect effect through systemic absorption." The letter notes that FDA objected to a similar implied safety claim ("Potency that STOPS in the lungs") on Oct. 15 and Nov. 7, 1997...