Glaxo Wellcome Flovent
Pharmacodynamic and pharmacokinetic comparisons of fluticasone and other inhaled corticosteroids in a Flovent detail aid represent "unsubstantiated implied superiority claims," FDA tells company in April 8 notice of violation letter. The detail aid claim that Flovent's oral bioavailablity is the lowest in the class lacks fair balance, FDA adds. Although the oral bioavailability is negligible (<1%), FDA points out that the majority of fluticasone delivered to the lung is systemically absorbed, making the systemic bioavailability about 30% of the dose delivered
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