OTC-Only PEG Market Nears After Court Passes On Stopping Rx ANDA Withdrawals
US circuit court rejects petitions from Breckenridge Pharmaceutical, Lannett Co., Nexgen Pharma and Paddock Labs to order FDA to conduct a hearing on their requests to sustain approvals for Rx PEG 3350 generics. FDA's approvals of the Rx ANDAs are set to expire Nov. 2; the agency said the Rx products were rendered unapproved in 2006 when the same formulation became available OTC.
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FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350 products on May 2 would cause a shortage of the drug available to consumers. Saying "it likely would be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal" of the Rx drugs by that date, FDA extends the deadline to Nov. 2.
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.