FDA — authorised 30 October 1958
- Application: NDA011664
- Marketing authorisation holder: MERCK
- Local brand name: DECADRON
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Palonosetron with Dexamethasone in United States
FDA authorised Palonosetron with Dexamethasone on 30 October 1958
Marketing authorisations
FDA — authorised 6 October 1959
- Application: NDA012071
- Marketing authorisation holder: MERCK
- Local brand name: DECADRON
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 July 1960
- Application: NDA012376
- Marketing authorisation holder: MERCK
- Local brand name: DECADRON
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 25 July 2003
- Application: NDA021372
- Marketing authorisation holder: HELSINN HLTHCARE
- Local brand name: ALOXI
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 22 August 2008
- Application: NDA022233
- Marketing authorisation holder: HELSINN HLTHCARE
- Local brand name: ALOXI
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Palonosetron with Dexamethasone 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 Palonosetron with Dexamethasone approved in United States?
Yes. FDA authorised it on 30 October 1958; FDA authorised it on 6 October 1959; FDA authorised it on 7 July 1960.
Who is the marketing authorisation holder for Palonosetron with Dexamethasone in United States?
MERCK holds the US marketing authorisation.