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# Janssen’s TB Drug Converted to Full Approval
- URL: https://www.fdaweb.com/janssens-tb-drug-converted-to-full-approval/
- Published: 2024-06-24T12:00:00.000Z
- Updated: 2026-09-14T14:34:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157240

FDA has converted Janssen’s [Sirturo (bedaquiline)](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmFjY2Vzc2RhdGEuZmRhLmdvdi9kcnVnc2F0ZmRhX2RvY3MvbGFiZWwvMjAyNC8yMDQzODRzMDE5bGJsLnBkZj91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwNjI0Ljk2Njk1NjUxIn0.QWIwWjxFhb8BDOSylAF-vs1JYLH9KTC%5F-8j1jUCGM3s/s/1255931999/br/244671293364-l?ref=fdaweb.com) from accelerated to traditional approval following a determination that a confirmatory trial verified clinical benefit. Sirturo is indicated for treating pulmonary tuberculosis (TB) due to *Mycobacterium tuberculosis* that is resistant to at least rifampin and isoniazid. The agency says the National TB Surveillance System [reported](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmNkYy5nb3YvbW13ci92b2x1bWVzLzczL3dyL21tNzMxMmE0Lmh0bT91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkjOn46dGV4dD1EdXJpbmclMjAyMDIzJTJDJTIwYSUyMHRvdGFsJTIwb2YsdGhhdCUyMGluJTIwMjAyMiUyMCgyLjUpLiIsImJ1bGxldGluX2lkIjoiMjAyNDA2MjQuOTY2OTU2NTEifQ.S1H0TerurwKlWdhY41CPhd4fgEkm%5F-hn0UR49mElfOk/s/1255931999/br/244671293364-l?ref=fdaweb.com) an increase in TB cases in the U.S. since 2020, including a 16% increase in overall cases in 2023 compared to 2022.

Sirturo was first approved in December 2012 under FDA’s accelerated approval pathway. As part of the initial approval, FDA required the company to conduct a confirmatory clinical study and develop a patient registry to assess rates of serious adverse events.