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

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.