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PEG 3350 Laxatives: FDA Allows Firms 6 Months To Make Their Case For Rx Products

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350 products on May 2 would cause a shortage of the drug available to consumers. Saying "it likely would be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal" of the Rx drugs by that date, FDA extends the deadline to Nov. 2.


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