FDA — authorised 18 June 2007
- Application: ANDA065369
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CEFEPIME HYDROCHLORIDE in United States
FDA authorised CEFEPIME HYDROCHLORIDE on 18 June 2007 · 1,059 US adverse-event reports
Marketing authorisations
FDA — authorised 20 March 2008
- Application: ANDA065441
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 2010
- Application: NDA050821
- Marketing authorisation holder: B BRAUN
- Status: supplemented
FDA — authorised 21 December 2010
- Application: ANDA090291
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 July 2012
- Application: ANDA202268
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 February 2016
- Application: ANDA203704
- Marketing authorisation holder: QILU ANTIBIOTICS
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 August 2018
- Application: ANDA209408
- Marketing authorisation holder: SAMSON MEDCL
- Local brand name: CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 21 July 2020
- Application: ANDA212721
- Marketing authorisation holder: ASTRAL
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 February 2024
- Application: NDA216165
- Marketing authorisation holder: ORCHID PHARMA
- Local brand name: EXBLIFEP
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 22 May 2024
- Application: ANDA214402
- Marketing authorisation holder: HIKMA
- Local brand name: CEFEPIME HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 1,059
Most-reported reactions
- Pyrexia — 178 reports (16.81%)
- Febrile Neutropenia — 168 reports (15.86%)
- Pneumonia — 135 reports (12.75%)
- Acute Kidney Injury — 102 reports (9.63%)
- Drug Ineffective — 100 reports (9.44%)
- Platelet Count Decreased — 83 reports (7.84%)
- Off Label Use — 80 reports (7.55%)
- Neutrophil Count Decreased — 72 reports (6.8%)
- Anaemia — 71 reports (6.7%)
- Diarrhoea — 70 reports (6.61%)
CEFEPIME HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CEFEPIME HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 18 June 2007; FDA authorised it on 20 March 2008; FDA authorised it on 6 May 2010.
Who is the marketing authorisation holder for CEFEPIME HYDROCHLORIDE in United States?
HOSPIRA INC holds the US marketing authorisation.