Ciba-Geigy's Q-Vel
Executive Summary
Company submitted safety analysis to FDA April 19 for nocturnal leg muscle cramp product in support of Category I status for quinine sulfate. The report, by Richard Aster, MD, Medical College of Wisconsin, reviewed effect of quinine on thrombocytopenia and concluded: "quinine used at recommended dosage appears to be an exceedingly safe medication." The agency is also evaluating final efficacy data submitted Feb. 28. At FDA's request, Ciba-Geigy recently submitted raw data from the efficacy study for further statistical analysis.
Company submitted safety analysis to FDA April 19 for nocturnal leg
muscle cramp product in support of Category I status for
quinine sulfate. The report, by Richard Aster, MD, Medical College
of Wisconsin, reviewed effect of quinine on thrombocytopenia and
concluded: "quinine used at recommended dosage appears to be an
exceedingly safe medication." The agency is also evaluating final
efficacy data submitted Feb. 28. At FDA's request, Ciba-Geigy
recently submitted raw data from the efficacy study for further
statistical analysis. |