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Rx PEG Firms Give FDA Deadline Before Asking Court To Delay ANDA Withdrawals

Executive Summary

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.

 

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