FDA — authorised 28 September 2016
- Application: ANDA090999
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Emend in United States
FDA authorised Emend on 28 September 2016
Marketing authorisations
FDA — authorised 12 October 2017
- Application: ANDA207777
- Marketing authorisation holder: GLENMARK SPECLT
- Status: approved
FDA — authorised 9 November 2017
- Application: NDA209296
- Marketing authorisation holder: HERON THERAPS INC
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 21 October 2020
- Application: ANDA211835
- Marketing authorisation holder: TORRENT
- Status: approved
FDA — authorised 5 March 2024
- Application: NDA216457
- Marketing authorisation holder: HERON THERAPS INC
- Indication: Labeling
- Status: approved
The FDA approved Emend, manufactured by Heron Theraps Inc, under the application number NDA216457 on 5 March 2024. The approved indication for Emend is listed in its labelling. This approval was granted through the standard expedited pathway.
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 28 September 2016; FDA authorised it on 12 October 2017; FDA authorised it on 9 November 2017.
Who is the marketing authorisation holder for Emend in United States?
SANDOZ holds the US marketing authorisation.