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

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