FDA — authorised 11 March 2003
- Application: NDA020671
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
🇺🇸 Nogitecan in United States
FDA authorised Nogitecan on 11 March 2003
Marketing authorisations
FDA — authorised 7 October 2011
- Application: NDA020981
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
FDA — authorised 26 June 2013
- Application: ANDA202351
- Marketing authorisation holder: ACCORD HLTHCARE
- Status: approved
FDA — authorised 28 September 2015
- Application: ANDA090620
- Marketing authorisation holder: ACTAVIS TOTOWA
- Indication: Labeling
- Status: approved
FDA — authorised 29 January 2016
- Application: NDA200582
- Marketing authorisation holder: HOSPIRA INC
- Indication: Labeling
- Status: approved
Nogitecan 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 Nogitecan approved in United States?
Yes. FDA authorised it on 11 March 2003; FDA authorised it on 7 October 2011; FDA authorised it on 26 June 2013.
Who is the marketing authorisation holder for Nogitecan in United States?
SANDOZ holds the US marketing authorisation.