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CIBA SUBMITS Q-VEL DATA REANALYSIS TO SUPPORT MONOGRAPH STATUS

This article was originally published in The Tan Sheet

Executive Summary

CIBA SUBMITS Q-VEL DATA REANALYSIS TO SUPPORT MONOGRAPH STATUS of the quinine sulfate/vitamin E combination product for the treatment of nocturnal leg cramps in a Jan. 25 filing with FDA. Ciba Consumer maintained that the reanalysis "clearly [demonstrates] that, on the basis of the primary effectiveness endpoints studied, the quinine sulfate/vitamin E combination in Q- Vel was superior to quinine sulfate alone, and that quinine sulfate was superior to placebo for the prevention of nighttime leg cramps." The statistical reanalysis of a previously submitted study from Bio-Products, the developer of Q-Vel, was conducted by Ciba at the request of FDA.
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