Ciba's request for OTC anti-cholesterol claim for psyllium rejected by FDA.
This article was originally published in The Tan Sheet
Executive Summary
CIBA's REQUEST FOR ANTI-CHOLESTEROL CLAIM FOR PSYLLIUM REJECTED BY FDA, which questioned the relatively small sample size in the four clinical trials submitted by the company to support adding the new indication to the OTC laxative monograph. "On the basis of these studies," FDA said in a Dec. 5 letter to Ciba Consumer, "we cannot recommend that psyllium be included as a cholesterol-lowering agent in the final monograph for OTC laxative drug products."
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