FDA — authorised 30 May 2007
- Application: NDA022088
- Marketing authorisation holder: PF PRISM CV
- Local brand name: TORISEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Torisel in United States
FDA authorised Torisel on 30 May 2007
Marketing authorisations
FDA — authorised 30 July 2018
- Application: ANDA203153
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: TEMSIROLIMUS
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 16 August 2019
- Application: ANDA207383
- Marketing authorisation holder: GLAND
- Status: approved
Torisel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Torisel approved in United States?
Yes. FDA authorised it on 30 May 2007; FDA authorised it on 30 July 2018; FDA authorised it on 16 August 2019.
Who is the marketing authorisation holder for Torisel in United States?
PF PRISM CV holds the US marketing authorisation.