FDA — authorised 11 October 1991
- Marketing authorisation holder: HOSPIRA INC
- Status: approved
🇺🇸 Nipent in United States
FDA authorised Nipent on 11 October 1991
Marketing authorisations
FDA — authorised 11 October 1991
- Application: NDA020122
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: NIPENT
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 September 2014
- Application: ANDA203554
- Marketing authorisation holder: RISING
- Local brand name: PENTOSTATIN
- Indication: INJECTABLE — INJECTION
- Status: approved
Nipent 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 Nipent approved in United States?
Yes. FDA authorised it on 11 October 1991; FDA authorised it on 11 October 1991; FDA authorised it on 19 September 2014.
Who is the marketing authorisation holder for Nipent in United States?
HOSPIRA INC holds the US marketing authorisation.