Benznidazole

Product manufactured by Exeltis Usa, Inc.

Application Nr Approved Date Route Status External Links
NDA209570 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Benznidazole Tablets Are Indicated In Pediatric Patients 2 To 12 Years Of Age For The Treatment Of Chagas Disease (American Trypanosomiasis) Caused By Trypanosoma Cruzi . This Indication Is Approved Under Accelerated Approval Based On The Number Of Treated Patients Who Became Immunoglobulin G (Igg) Antibody Negative Against The Recombinant Antigens Of T. Cruzi [See Clinical Studies ( 14 )] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials. Benznidazole Tablets, A Nitroimidazole Antimicrobial, Is Indicated In Pediatric Patients 2 To 12 Years Of Age For The Treatment Of Chagas Disease (American Trypanosomiasis), Caused By Trypanosoma Cruzi ( 1 ). This Indication Is Approved Under Accelerated Approval Based On The Number Of Treated Patients Who Became Immunoglobulin G (Igg) Antibody Negative Against The Recombinant Antigens Of T. Cruzi . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In Confirmatory Trials ( 1 , 14 ).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Benznidazole BENZNIDAZOLE ZINC56949

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