FDA — authorised 24 September 2012
- Application: ANDA090999
- Marketing authorisation holder: SANDOZ
- Local brand name: APREPITANT
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 EMEND in United States
FDA authorised EMEND on 24 September 2012 · 9,147 US adverse-event reports
Marketing authorisations
FDA — authorised 9 November 2017
- Application: NDA209296
- Marketing authorisation holder: HERON THERAPS INC
- Local brand name: CINVANTI
- Indication: EMULSION — INTRAVENOUS
- Status: approved
FDA — authorised 21 October 2020
- Application: ANDA211835
- Marketing authorisation holder: TORRENT
- Local brand name: APREPITANT
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 September 2022
- Application: NDA216457
- Marketing authorisation holder: HERON THERAPS INC
- Local brand name: APONVIE
- Indication: EMULSION — INTRAVENOUS
- Status: approved
FDA — authorised 5 March 2026
- Application: ANDA218851
- Marketing authorisation holder: MYLAN
- Local brand name: APREPITANT
- Indication: EMULSION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA216976
- Marketing authorisation holder: MYLAN PHARMACEUTICALS INC
- Local brand name: APREPITANT
- Indication: INJECTION, EMULSION
- Status: approved
FDA
- Application: NDA218754
- Marketing authorisation holder: AZURITY
- Local brand name: APREPITANT
- Indication: INJECTABLE — INTRAVENOUS
- 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: 22 April 2025 – 22 April 2026
- Total reports: 9,147
Most-reported reactions
- Nausea — 1,380 reports (15.09%)
- Dyspnoea — 1,032 reports (11.28%)
- Diarrhoea — 1,019 reports (11.14%)
- Pyrexia — 1,011 reports (11.05%)
- Vomiting — 979 reports (10.7%)
- Fatigue — 875 reports (9.57%)
- Febrile Neutropenia — 734 reports (8.02%)
- Off Label Use — 724 reports (7.92%)
- Rash — 703 reports (7.69%)
- Alopecia — 690 reports (7.54%)
Other Oncology approved in United States
Frequently asked questions
Is EMEND approved in United States?
Yes. FDA authorised it on 24 September 2012; FDA authorised it on 9 November 2017; FDA authorised it on 21 October 2020.
Who is the marketing authorisation holder for EMEND in United States?
SANDOZ holds the US marketing authorisation.