In Brief: Magnesium citrate powder in laxatives
This article was originally published in The Tan Sheet
Executive Summary
Magnesium citrate powder in laxatives: U.S. Pharmacopeia revision committee approves draft monograph for magnesium citrate powder oral solution. The monograph is published in the May-June Pharmacopeial Forum, Purdue Frederick tells FDA in a May 6 resubmitted citizen petition. The petition seeks inclusion of the ingredient in the laxative monograph. The company submitted its original petition in October 1994. Two months later, FDA denied the request, expressing concerns about solubility and the safety of the dosage form. The agency also suggested that the company develop a USP monograph and resubmit the petition ("The Tan Sheet" Jan. 9, 1995, p. 10). The petition requests clarification that the saline active ingredient magnesium citrate may be supplied in any dosage form, including a solid mixture to be reconstituted prior to oral administration...
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