FDA Rejects Arguments On Keeping Rx PEG Products Available
This article was originally published in The Tan Sheet
Executive Summary
FDA responded to arguments in its proposed order denying drug firms’ requests to allow their RX polyethylene glycol 3350 products to remain on the market. Among the arguments, all rejected by FDA, was that a prescription PEG 3350 should be available for use by pediatric patients and that the product is not safe OTC for elderly consumers.
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