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.
You may also be interested in...
Attapulgite, Polycarbophil Excluded From OTC Antidiarrheal Final Monograph
Activated attapulgite is reclassified from proposed Category I status to nonmonograph in the 1OTC Antidiarrheal Drug Products final monograph, published in the April 17 Federal Register
Attapulgite, Polycarbophil Excluded From OTC Antidiarrheal Final Monograph
Activated attapulgite is reclassified from proposed Category I status to nonmonograph in the 1OTC Antidiarrheal Drug Products final monograph, published in the April 17 Federal Register
Attapulgite, Polycarbophil Excluded From OTC Antidiarrheal Final Monograph
Activated attapulgite is reclassified from proposed Category I status to nonmonograph in the 1OTC Antidiarrheal Drug Products final monograph, published in the April 17 Federal Register