1. Pink Sheet

FDA Rejects Arguments On Keeping Rx PEG Products Available

 
• By Malcolm Spicer

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.

Points raised in arguments by firms asking FDA to allow their Rx polyethylene glycol 3350 products to remain on the market include that a prescription version should be available for use by pediatric patients and that removing their products will nearly triple the cost of the product for the average insured consumers,

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