FDA — authorised 26 March 2003
- Application: NDA021549
- Marketing authorisation holder: MSD
- Local brand name: EMEND
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Emend in United States
FDA authorised Emend on 26 March 2003
Marketing authorisations
FDA — authorised 27 March 2003
- Status: approved
FDA — authorised 17 December 2015
- Application: NDA207865
- Marketing authorisation holder: MSD MERCK CO
- Local brand name: EMEND
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 September 2019
- Application: ANDA211860
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Status: approved
FDA — authorised 5 September 2019
- Application: ANDA212309
- Marketing authorisation holder: BE PHARMS
- Status: approved
FDA — authorised 9 December 2020
- Application: ANDA211160
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 14 April 2023
- Application: ANDA214616
- Marketing authorisation holder: ASPIRO
- Indication: Labeling
- Status: approved
FDA — authorised 29 May 2025
- Application: NDA216686
- Marketing authorisation holder: STERISCIENCE
- Indication: Labeling
- Status: approved
The FDA approved Emend, a product of STERISCIENCE, on 29 May 2025. The approval was granted under the standard expedited pathway. Emend's approved indication is for its labelling, but the specific local brand name is not reported.
Emend 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 Emend approved in United States?
Yes. FDA authorised it on 26 March 2003; FDA authorised it on 27 March 2003; FDA authorised it on 17 December 2015.
Who is the marketing authorisation holder for Emend in United States?
MSD holds the US marketing authorisation.