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Marion Carafate advertising

Executive Summary

The company met with FDA Division of Drug Advertising and Labeling on April 10 to discuss remedial actions that the agency requested in a March 14 reg letter. In objecting to Marion's continuing promotions that imply that Carafate is useful for NSAID-induced ulcers and other unapproved uses. FDA told the firm that it should send a corrective letter to every U.S. physician and run corrective ads in medical journals ("The Pink Sheet" March 27, p. 9).
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PS015435

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