Agoral Laxative With Senna Being Relaunched By Numark Labs
This article was originally published in The Tan Sheet
Executive Summary
Numark Laboratories is introducing reformulated Agoral liquid laxative in the U.S. and Canada under a licensing agreement with Warner-Lambert. The new product is formulated with the active ingredient senna extract containing sennosides USP 25 mg.
You may also be interested in...
Senna Safety To Be Studied By Purdue, Madaus, Novartis, Reckitt & Colman
Laxative product manufacturer Purdue Pharma (Senokot) is working with Madaus AG (Agiolax), Novartis Consumer Health (Ex-Lax) and Reckitt & Colman (Senokot overseas) to "comparatively analyze" natural senna as well as sennoside laxative active ingredients, Purdue told FDA in a June 30 letter made available recently. The firm had agreed to conduct a two-year safety study on the laxative ingredient in a Sept. 3 letter to the agency (1"The Tan Sheet" Sept. 28, 1998, In Brief).
Phenolphthalein Banned In OTC Laxatives Effective Jan. 28
FDA's final rule banning the use of phenolphthalein in OTC stimulant laxatives based on safety concerns was published in the Jan. 28 Federal Register. The rule is effective immediately.
Bisacodyl, senna OTC laxative safety data requested by June 1999 in FDA proposal.
BISACODYL, SENNA OTC LAXATIVE SAFETY DATA REQUESTED BY JUNE 1999 in an FDA proposed rule published in the June 19 Federal Register. As expected, the proposal tentatively reclassifies senna, bisacodyl, cascara sagrada and aloe from Category I (safe and effective) to Category III (further testing needed) in the tentative final monograph for OTC laxatives and reopens the administrative record for data considered necessary to establish the safety of the ingredients.