FDA — authorised 15 June 2007
- Application: NDA021875
- Marketing authorisation holder: NUVO PHARMS
- Local brand name: NUVIGIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Nuvigil in United States
FDA authorised Nuvigil on 15 June 2007
Marketing authorisations
FDA — authorised 1 June 2012
- Application: ANDA200043
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: ARMODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2012
- Application: ANDA200156
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: ARMODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2016
- Application: ANDA200751
- Marketing authorisation holder: LUPIN
- Local brand name: ARMODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 2016
- Application: ANDA202768
- Marketing authorisation holder: NATCO PHARMA LTD
- Status: approved
FDA — authorised 6 March 2018
- Application: ANDA206069
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ARMODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 2019
- Application: ANDA201514
- Marketing authorisation holder: COREPHARMA
- Local brand name: ARMODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA200152
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: ARMODAFINIL
- Indication: TABLET — ORAL
- Status: approved
Nuvigil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Nuvigil approved in United States?
Yes. FDA authorised it on 15 June 2007; FDA authorised it on 1 June 2012; FDA authorised it on 29 August 2012.
Who is the marketing authorisation holder for Nuvigil in United States?
NUVO PHARMS holds the US marketing authorisation.