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FDA withdrawing Rx laxative ANDAs

This article was originally published in The Tan Sheet

Executive Summary

FDA offers opportunities to firms marketing prescription laxatives containing polyethylene glycol 3350, which Schering-Plough has marketed OTC with MiraLax since late 2007, to contest the agency's proposal to withdraw approval for the Rx products. In an Oct. 24 Federal Register notice, FDA says in April 2007 it proposed withdrawing the abbreviated new drug applications for PEG 3350 held by Schwarz Pharma, Kali Laboratories, Nexgen Pharma, Coastal Pharmaceuticals and Teva Pharmaceutical Industries. After approving the MiraLax switch application in December 2006, FDA was required to remove prescription PEG 3350 drugs from the market because the Food, Drug and Cosmetic Act does not permit both Rx and OTC versions of the same product to be marketed at the same time, the agency says. None of the five manufacturers with an ANDA for prescription PEG 3350 have asked about changing their product labels to the approved OTC labeling or about voluntarily withdrawing the ANDAs. Each of the five firms has until Nov. 24 to ask FDA to schedule a hearing to contest the proposal. According to the notice, S-P's exclusivity for OTC MiraLax sales expired this month

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