FDA — authorised 15 December 2004
- Application: NDA021476
- Marketing authorisation holder: WAYLIS THERAP
- Status: supplemented
🇺🇸 Lunesta in United States
FDA authorised Lunesta on 15 December 2004
Marketing authorisations
FDA — authorised 23 May 2011
- Application: ANDA091169
- Marketing authorisation holder: TEVA
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 July 2011
- Application: ANDA091165
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2011
- Application: ANDA091124
- Marketing authorisation holder: LUPIN LTD
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 March 2013
- Application: ANDA091151
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 April 2013
- Application: ANDA091103
- Marketing authorisation holder: SUN PHARM
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 April 2014
- Application: ANDA091166
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2014
- Application: ANDA091113
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 2015
- Application: ANDA202929
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 January 2024
- Application: ANDA205504
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ESZOPICLONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Lunesta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Lunesta approved in United States?
Yes. FDA authorised it on 15 December 2004; FDA authorised it on 23 May 2011; FDA authorised it on 14 July 2011.
Who is the marketing authorisation holder for Lunesta in United States?
WAYLIS THERAP holds the US marketing authorisation.