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US seeks market withdrawal of Miralax generics

This article was originally published in Scrip

Executive Summary

The US FDAis proposing to withdraw approval of generic prescription versions of the laxative polyethylene glycol because the reference product, Schering-Plough's Miralax, was switched from Rx to over-the-counter status in 2006. The ANDAs are held by Schwarz Pharma (UCB), Kali Laboratories (Par Pharmaceutical), Nexgen Pharma, Coastal Pharmaceuticals and Teva Pharmaceutical Industries. The Food, Drug and Cosmetic Act does not permit both Rx and OTC versions of the same drug product to be marketed at the same time. The agency is giving the ANDA holders an opportunity to request a hearing before withdrawing approval.


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