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.
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