FDA — authorised 14 June 1996
- Application: NDA020571
- Marketing authorisation holder: PFIZER INC
- Local brand name: CAMPTOSAR
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CPT-11 in United States
FDA authorised CPT-11 on 14 June 1996
Marketing authorisations
FDA — authorised 27 February 2008
- Application: ANDA077776
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA077915
- Marketing authorisation holder: HOSPIRA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA078589
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA077994
- Marketing authorisation holder: SANDOZ
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 April 2008
- Application: ANDA078805
- Marketing authorisation holder: SUN PHARMA GLOBAL
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 2008
- Application: ANDA090101
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 November 2009
- Application: ANDA090137
- Marketing authorisation holder: SANDOZ
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2010
- Application: ANDA078953
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 February 2012
- Application: ANDA200771
- Marketing authorisation holder: EMCURE PHARMS LTD
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2018
- Application: ANDA208718
- Marketing authorisation holder: SHILPA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 November 2020
- Application: ANDA213278
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
CPT-11 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 CPT-11 approved in United States?
Yes. FDA authorised it on 14 June 1996; FDA authorised it on 27 February 2008; FDA authorised it on 27 February 2008.
Who is the marketing authorisation holder for CPT-11 in United States?
PFIZER INC holds the US marketing authorisation.