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OTC-Only PEG Market Nears After Court Passes On Stopping Rx ANDA Withdrawals

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

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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