Pepto-Bismol pediatric dosing
This article was originally published in The Tan Sheet
Executive Summary
FDA denies P&G's request to defer bismuth subsalicylate pediatric dosing from the antidiarrheal final monograph in a Nov. 8 letter to the firm ("The Tan Sheet" Oct. 11, p. 13). However, the agency told P&G that "should relevant data be submitted to the agency before the effective date of the final monograph, consideration will be given to deferring pediatric doses for bismuth subsalicylate" from the final monograph. P&G is conducting clinical studies on bismuth subsalicylate pediatric dosing.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning