Application Nr Approved Date Route Status External Links
ANDA209105 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Atovaquone Oral Suspension Usp Is A Quinone Antimicrobial Drug Indicated For: Prevention Of Pneumocystis Jirovecii Pneumonia (Pcp) In Adults And Adolescents Aged 13 Years And Older Who Cannot Tolerate Trimethoprim Sulfamethoxazole (Tmp-Smx). ( 1.1 ) Treatment Of Mild-To-Moderate Pcp In Adults And Adolescents Aged 13 Years And Older Who Cannot Tolerate Tmp-Smx. ( 1.2 ) Limitations Of Use ( 1.3 ): Treatment Of Severe Pcp (Alveolar Arterial Oxygen Diffusion Gradient [(A-A)do 2 ]>45 Mm Hg) With Atovaquone Oral Suspension Usp Has Not Been Studied. The Efficacy Of Atovaquone Oral Suspension Usp In Subjects Who Are Failing Therapy With Tmp Smx Has Also Not Been Studied. 1.1 Prevention Of Pneumocystis Jirovecii Pneumonia Atovaquone Oral Suspension Usp Is Indicated For The Prevention Of Pneumocystis Jirovecii Pneumonia (Pcp) In Adults And Adolescents (Aged 13 Years And Older) Who Cannot Tolerate Trimethoprim-Sulfamethoxazole (Tmp-Smx). 1.2 Treatment Of Mild-To-Moderate Pneumocystis Jirovecii Pneumonia Atovaquone Oral Suspension Usp Is Indicated For The Acute Oral Treatment Of Mild-To-Moderate Pcp In Adults And Adolescents (Aged 13 Years And Older) Who Cannot Tolerate Tmp-Smx. 1.3 Limitations Of Use Clinical Experience With Atovaquone Oral Suspension Usp For The Treatment Of Pcp Has Been Limited To Subjects With Mild-To-Moderate Pcp (Alveolar-Arterial Oxygen Diffusion Gradient [(A-A)do 2 ] ≤45 Mm Hg). Treatment Of More Severe Episodes Of Pcp With Atovaquone Oral Suspension Usp Has Not Been Studied. The Efficacy Of Atovaquone Oral Suspension Usp In Subjects Who Are Failing Therapy With Tmp-Smx Has Also Not Been Studied.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Atovaquone ATOVAQUONE ZINC100017856

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