PPA AER Underreporting Probable, NDAC Says In Vote Against GRAS Status
This article was originally published in The Tan Sheet
Executive Summary
An estimated 200-500 hemorrhagic strokes a year in people ages 18-49 can be attributed to phenylpropanolamine, FDA's Office of Postmarketing Drug Risk Assessment told the Nonprescription Drugs Advisory Committee at a meeting in Gaithersburg, Md. Oct. 19.
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FDA would "assure the removal" of OTC drugs containing phenylpropanolamine (PPA) from the market and "prohibit future marketing of such products" under a proposed rule published in the Federal Register Dec. 22
Official PPA Removal From Market Sought In FDA Proposed Rule
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