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QUININE-BASED DRUGS FOR NOCTURNAL LEG MUSCLE CRAMPS CANNOT BE SOLD

This article was originally published in The Tan Sheet

Executive Summary

QUININE-BASED DRUGS FOR NOCTURNAL LEG MUSCLE CRAMPS CANNOT BE SOLD after February 1995 under FDA's OTC nocturnal leg muscle cramps final rule, which is expected to be published during the week of Aug. 22. FDA concluded that "new information has raised serious safety concerns over the OTC availability of quinine sulfate for this use." Quinine was classified in Category III (data insufficient to permit classification) in the November 1985 tentative final monograph for OTC nocturnal leg muscle cramp drugs.

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