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SCHERING PROVENTIL HFA COLD TEMPERATURE CLAIM IN PRESS RELEASE LACKS BALANCE, FDA SAYS; GLAXO FLOVENT EFFICACY COMPARISON TO BECLOMETHASONE CITED

Executive Summary

Schering-Plough's claim that its chlorofluorocarbon-free albuterol inhaler Proventil HFA contains a propellant that remains aerosolizable even when used at colder outdoor temperatures is misleading because it does not include a fair balance disclaimer, FDA's Division of Drug Marketing, Advertising & Communications said in a May 7 letter to the company.
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