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Berlex

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Executive Summary

Sends Quinaglute Dura-Tabs "Dear Doctor" letter May 27 to 46,443 health care professionals in response to FDA's April 2 warning letter on company promotion of the quinidine gluconate sustained-release tablets ("The Pink Sheet" April 12, p. 12). The letter notes that the Berlex product has "not been demonstrated to be safer or more effective that any other sustained-release quinidine gluconate tablet with an 'AB' rating"; that Quinaglute Dura-Tabs "should not be universally dosed BID...as suggested in our previous promotional materials"; and that "there are no adequate and well-controlled studies to support our previous claims that Quinaglute Dura-Tabs Tablets have either a lower incidence of GI side effects or a lower discontinuation rate than any other Class I antiarrhythmic product".

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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