Transcription of Reference ID: 2953262
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NDA 201,699 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DIFICID safely and effectively. See full prescribing information for DIFICID. DIFICID ( fidaxomicin ) tablets, for oral use Initial approval: 2011 To reduce the development of drug resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile.
Fidaxomicin is mainly confined to the gastrointestinal tract following oral administration. In selected patients (N=8) treated with DIFICID 200 mg twice daily for 10 days from
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