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.
You may also be interested in...
Rx PEG Firms Give FDA Deadline Before Asking Court To Delay ANDA Withdrawals
Breckenridge Pharmaceuticals and Nexgen Pharma file a citizen petition asking FDA to delay effective date for the agency's order that withdrawing approval of all abbreviated new drug applications for Rx generic polyethylene glycol 3350 laxatives. Absent quick reply, the companies may seek emergency court action.
FDA Rejects Arguments On Keeping Rx PEG Products Available
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.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.