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FDA seeks dismissal of 'premature' Mylan suit on Ranbaxy's generic Lipitor

This article was originally published in Scrip

Executive Summary

The US FDA has asked a federal judge to throw out Mylan's lawsuit seeking a ruling that the agency must "immediately decide" and "make public" its position on the status of Ranbaxy's ANDA and the exclusivity issue surrounding a generic version of Pfizer's Lipitor (atorvastatin). The regulator argues that a judgment would be premature because there are outstanding technical issues on all of the Lipitor ANDAs and that Mylan has failed to state a valid claim for unreasonable delay under the Administrative Procedures Act.


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