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

 
• By Malcolm Spicer

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.

Manufacturers of Rx generic polyethylene glycol 3350 laxatives now have until Nov. 2 to convince FDA or a court to allow their products to remain on the market, after the agency extended its deadline by six months on withdrawing approval of their abbreviated new drug applications.

The previous withdrawal date of May 2 for the polyethylene glycol (PEG) 3350 ANDAs had been imposed by an April...

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