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1 Indications And Usage Limited Population: Pretomanid Tablet Is Indicated, As Part Of A Combination Regimen With Bedaquiline And Linezolid For The Treatment Of Adults With Pulmonary Extensively Drug Resistant (Xdr) Or Treatment-Intolerant Or Nonresponsive Multidrug-Resistant (Mdr) Tuberculosis (Tb). Approval Of This Indication Is Based On Limited Clinical Safety And Efficacy Data. This Drug Is Indicated For Use In A Limited And Specific Population Of Patients. Limitations Of Use: • Pretomanid Tablets Are Not Indicated In Patients With The Following Conditions: O Drug-Sensitive (Ds) Tuberculosis O Latent Infection Due To Mycobacterium Tuberculosis. O Extra-Pulmonary Infection Due To Mycobacterium Tuberculosis. O Mdr-Tb That Is Not Treatment-Intolerant Or Nonresponsive To Standard Therapy. • Safety And Effectiveness Of Pretomanid Tablets Have Not Been Established For Its Use In Combination With Drugs Other Than Bedaquiline And Linezolid As Part Of The Recommended Dosing Regimen [See Dosage And Administration (2.2) ] . Limited Population: Pretomanid Tablet Is An Antimycobacterial Indicated, As Part Of A Combination Regimen With Bedaquiline And Linezolid For The Treatment Of Adults With Pulmonary Extensively Drug Resistant (Xdr), Treatment-Intolerant Or Nonresponsive Multidrug‑resistant (Mdr) Tuberculosis (Tb). Approval Of This Indication Is Based On Limited Clinical Safety And Efficacy Data. This Drug Is Indicated For Use In A Limited And Specific Population Of Patients. ( 1 ) Limitations Of Use ( 1 ): • Pretomanid Tablets Are Not Indicated For Patients With: • Drug-Sensitive (Ds) Tuberculosis • Latent Infection Due To Mycobacterium Tuberculosis • Extra-Pulmonary Infection Due To Mycobacterium Tuberculosis • Mdr-Tb That Is Not Treatment-Intolerant Or Nonresponsive To Standard Therapy • Safety And Effectiveness Of Pretomanid Tablets Have Not Been Established For Its Use In Combination With Drugs Other Than Bedaquiline And Linezolid As Part Of The Recommended Dosing Regimen.
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