PEG 3350 Rx ANDA Holder Gets Things Moving in the D.C. Circuit

By Sara W. Koblitz — On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit. The Petition seeks review of a final FDA order published in the Federal Register on April 2, 2018 (the “Order”). The Order denied requests for a hearing and withdrew approval for ANDAs for prescription polyethylene glycol 3350 (PEG-3350). The Order was initially effective May 2, 2018 but was stayed by FDA in response to several petitions for stay to the Agency. Currently, the Order goes into effect on November 2, 2018 – but FDA may not have the final say on this issue. Breckenridge/Nexgen’s asks the D.C. Circuit to set aside the Order as clearly erroneous, arbitrary and capricious, an abuse of discretion, and not supported by substantial evidence. The Petition for Review is not a surprise. Breckenridge/Nexgen was one of several Rx ANDA…

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