PSYLLIUM/DOCUSATE SALTS INCLUSION IN LAXATIVE MONOGRAPH URGED

Executive Summary

PSYLLIUM/DOCUSATE SALTS INCLUSION IN LAXATIVE MONOGRAPH URGED by Procter & Gamble in a Dec. 28 letter to FDA. P&G requested that the agency permit docusate sodium/psyllium and docusate calcium/psyllium as Category I (safe and effective) combinations under the OTC laxative products monograph. In a September 1993 notice of proposed rulemaking to amend the laxative tentative final monograph, FDA concluded that oral dosage forms of docusate sodium and docusate calcium and rectal enema dosage forms of docusate potassium are Category I as stool-softener laxative ingredients ("The Tan Sheet" Sept. 6, 1993, p. 5). P&G markets the psyllium-based laxative Metamucil.