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

 
• By Malcolm Spicer

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.  

Two Rx generic polyethylene glycol 3350 laxative marketers are asking FDA to delay the May 2 effective date in a recent agency order that leaves available only OTC drugs with the same formulation. If FDA doesn't respond by April 13 on whether it will do so, they may seek a court order for a delay.

Attorneys for Breckenridge Pharmaceutical Inc. and Nexgen Pharma Inc. have submitted an April 6 citizen petition to FDA on the matter. At issue is an April 2 final order that withdraws approval of all abbreviated new drug applications for Rx generic polyethylene glycol (PEG) 3350 products

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