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Schering-Plough Asmanex

Executive Summary

Dose counter mechanism for mometasone furoate dry powder inhaler "has not been proven to be accurate or reliable," Jan. 19 FDA 483 inspection report states. Manual counts did not match the numbers displayed by the inhaler device's counter, FDA observed. The counting mechanism also exhibited "jamming" and would not decrement as intended. The once-daily corticosteroid has been "approvable" since October 1999 for treatment of asthma in patients 12 and older. The 483 was released by Public Citizen March 1 (1see related story, p. 6)
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PS037448

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