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KAOLIN/PECTIN "FIXED" COMBINATIONS DEEMED NOT SAFE AND EFFECTIVE

This article was originally published in The Tan Sheet

Executive Summary

KAOLIN/PECTIN "FIXED" COMBINATIONS DEEMED NOT SAFE AND EFFECTIVE for the treatment of acute nonspecific diarrhea, FDA told Upjohn in a June 15 letter. Based on six studies on kaolin and pectin, the agency determined that "the data and information submitted are insufficient to reclassify kaolin and pectin as a 'fixed' combination" from Category III (data insufficient to permit classification) to Category I (safe and effective). The "fixed" combination sought by Upjohn consists of 45 parts kaolin to one part pectin.
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