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Rhone-Poulenc Rorer Azmacort

Executive Summary

Lung deposition data for inhaled products must be correlated with clinical effects before they can be used in promotional materials, FDA tells RPR July 9. A company claim that Azmacort (triamcinolone) "delivers the right dose to the right place every time" implies clinical benefit without any supportive data, FDA says. Referring to a Feb. 26 discussion with the company, FDA reminds RPR that clinical pharmacology PET imaging, as used in the ad to illustrate lung deposition, is "not a validated surrogate measure of clinical effect." The agency also found that the phrases "right dose" and "right place" imply superiority over other orally-inhaled products: "i.e., any other dose to any other place is wrong or inappropriate," the letter concludes
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PS032646

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