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In Brief: Questran petition

This article was originally published in The Tan Sheet

Executive Summary

Questran petition: FDA "effectively grants" citizen petition submitted Sept. 25 by Rohm & Haas asking the agency to deny an Rx-to-OTC switch application for Bristol-Myers Squibb's Questran and Questran Light, FDA notes in an April 8 letter to the D.C.-based firm McKenna & Cuneo, which filed the petition on the company's behalf. The agency issued a guidance Oct. 27 concluding it will not currently permit the OTC marketing of drugs to treat hypercholesterolemia. Therefore, FDA states, it is "unnecessary to address the specific arguments presented in your petition." The agency adds, however, that "the decision not to address the specific argument should not be interpreted as agreement with the points you make." Rohm & Haas, which manufactures generic versions of the active ingredient in Questran, argued that safe use of the cholestyramine resin drug is not assured without the supervision of a physician ("The Tan Sheet" Oct. 6, 1997, p. 3)...

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