FDA — authorised 28 December 2012
- Application: NDA204384
- Marketing authorisation holder: JANSSEN THERAP
- Local brand name: SIRTURO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Bedaquiline Oral Tablet in United States
FDA authorised Bedaquiline Oral Tablet on 28 December 2012
Marketing authorisation
Bedaquiline Oral Tablet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Bedaquiline Oral Tablet approved in United States?
Yes. FDA authorised it on 28 December 2012.
Who is the marketing authorisation holder for Bedaquiline Oral Tablet in United States?
JANSSEN THERAP holds the US marketing authorisation.