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Duramed and estrogens

Executive Summary

FDA refuses generic firm's request for an indefinite extension of the June 15 deadline for replies to the agency's proposed withdrawal of all ANDAs for generic conjugated estrogens on June 12. Duramed had sought the extension in a June 4 petition in which it alleged that FDA's May 4 ad hoc subcommittee on conjugated estrogens meeting was prejudiced by several panel members with conflicts of interest.
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PS017653

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