FDA — authorised 15 September 1999
- Application: NDA021083
- Marketing authorisation holder: PF PRISM CV
- Local brand name: RAPAMUNE
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Rapamune in United States
FDA authorised Rapamune on 15 September 1999
Marketing authorisations
FDA — authorised 25 August 2000
- Application: NDA021110
- Marketing authorisation holder: PF PRISM CV
- Local brand name: RAPAMUNE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 2021
- Application: NDA213312
- Marketing authorisation holder: AADI SUB
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 22 March 2022
- Application: NDA213478
- Marketing authorisation holder: NOBELPHARMA
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 19 January 2023
- Application: ANDA216728
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 28 July 2023
- Application: ANDA211212
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
FDA — authorised 16 September 2024
- Application: ANDA215080
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
Rapamune 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 Rapamune approved in United States?
Yes. FDA authorised it on 15 September 1999; FDA authorised it on 25 August 2000; FDA authorised it on 22 November 2021.
Who is the marketing authorisation holder for Rapamune in United States?
PF PRISM CV holds the US marketing authorisation.