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Phillips Milk of Magnesia data "inadequate" to support stool softener indication -- FDA.

This article was originally published in The Tan Sheet

Executive Summary

PHILLIPS' MILK OF MAGNESIA DATA "INADEQUATE" to support a stool softener laxative indication, FDA said in an Aug. 3 response to a 1994 citizen petition from Sterling Health. The agency said it has reviewed the petition and "finds the data inadequate to support the effectiveness of 1,200 mg of magnesium hydroxide as a Category I [safe and effective] stool softener laxative." The Sterling U.S. business was acquired by Bayer in the autumn of 1994.
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