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FDA Almost Ready To Close Door On Rx Versions Of MiraLAX

This article was originally published in The Tan Sheet

Executive Summary

FDA drug center Director Janet Woodcock says the agency “concluded there is no genuine and substantial issues that precludes the withdrawal” of approval of ANDAs for generic Rx polyethylene glycol 3350 products. But FDA is allowing firms with the ANDAs 60 days to again argue their positions.

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