FDA — authorised 11 October 1991
- Application: NDA020122
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: NIPENT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Nipent in United States
FDA authorised Nipent on 11 October 1991 · 146 US adverse-event reports
Marketing authorisations
FDA — authorised 7 August 2007
- Application: ANDA077841
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: PENTOSTATIN
- 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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 19 April 2025 – 19 April 2026
- Total reports: 146
Most-reported reactions
- Dyspnoea — 20 reports (13.7%)
- Pyrexia — 19 reports (13.01%)
- Nausea — 17 reports (11.64%)
- Renal Failure Acute — 14 reports (9.59%)
- Sepsis — 14 reports (9.59%)
- Diarrhoea — 13 reports (8.9%)
- Hypotension — 13 reports (8.9%)
- Vomiting — 13 reports (8.9%)
- Dehydration — 12 reports (8.22%)
- Neutrophil Count Decreased — 11 reports (7.53%)
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 7 August 2007; 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.