🇺🇸 SIROLIMUS in United States

FDA authorised SIROLIMUS on 15 September 1999

Marketing authorisations

FDA — authorised 15 September 1999

  • Application: NDA021083
  • Marketing authorisation holder: PF PRISM CV
  • Status: supplemented

FDA — authorised 25 August 2000

  • Application: NDA021110
  • Marketing authorisation holder: PF PRISM CV
  • Status: supplemented

FDA — authorised 18 October 2019

  • Application: ANDA211212
  • Marketing authorisation holder: AMNEAL
  • Status: approved

FDA — authorised 19 January 2023

  • Application: ANDA216728
  • Marketing authorisation holder: MSN
  • Status: approved

FDA — authorised 16 September 2024

  • Application: ANDA215080
  • Marketing authorisation holder: HETERO LABS LTD V
  • Status: approved

FDA

  • Status: approved

SIROLIMUS in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is SIROLIMUS approved in United States?

Yes. FDA authorised it on 15 September 1999; FDA authorised it on 25 August 2000; FDA authorised it on 18 October 2019.

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

PF PRISM CV holds the US marketing authorisation.