🇺🇸 Sirturo in United States

FDA authorised Sirturo on 21 June 2024

Marketing authorisation

FDA — authorised 21 June 2024

  • Application: NDA204384
  • Marketing authorisation holder: JANSSEN THERAP
  • Indication: Efficacy
  • Status: approved

The US FDA approved Sirturo, a drug developed by Janssen Therapeutics, on 21 June 2024. The approval was granted under the standard expedited pathway, with the application number NDA204384. The marketing authorisation holder is Janssen Therapeutics, and the local brand name is not reported. The efficacy of Sirturo has been approved for a specific indication, although the exact indication is not specified in the available data.

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Sirturo 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 Sirturo approved in United States?

Yes. FDA authorised it on 21 June 2024.

Who is the marketing authorisation holder for Sirturo in United States?

JANSSEN THERAP holds the US marketing authorisation.