In Brief: Phenolphthalein meeting
This article was originally published in The Tan Sheet
Executive Summary
Phenolphthalein meeting: OTC "feedback" meeting between FDA and Novartis on phenolphthalein scheduled for Dec. 11. In comments filed last June in anticipation of the agency's proposed ban of the ingredient, Novartis proposed a case-control human surveillance study to better assess whether the use of phenolphthalein-containing laxatives are cause for safety concern ("The Tan Sheet" June 23, p. 9). The company also submitted a report by CanTox consultants that reviewed both new and existing National Toxicology Program data on the ingredient. FDA's proposal was published in September; Novartis responded to the proposed ban by reformulating Ex-Lax with senna ("The Tan Sheet" Sept. 1, p. 1). The feedback meeting will begin at 3:30 p.m. in Room 200A of FDA's Rockville, Md. offices at 9201 Corporate Boulevard...