🇺🇸 VARENICLINE in United States

FDA authorised VARENICLINE on 12 June 2023

Marketing authorisations

FDA — authorised 12 June 2023

  • Application: ANDA216723
  • Marketing authorisation holder: ZYDUS
  • Status: approved

FDA — authorised 25 July 2023

  • Application: ANDA217151
  • Marketing authorisation holder: KANCHAN HLTHCARE
  • Status: approved

FDA — authorised 23 August 2023

  • Application: ANDA214557
  • Marketing authorisation holder: ALKEM LABS LTD
  • Status: approved

FDA — authorised 23 October 2023

  • Application: ANDA214571
  • Marketing authorisation holder: HETERO LABS LTD III
  • Status: approved

FDA — authorised 4 December 2023

  • Application: ANDA211862
  • Marketing authorisation holder: LUPIN LTD
  • Status: approved

FDA

  • Status: approved

VARENICLINE 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 VARENICLINE approved in United States?

Yes. FDA authorised it on 12 June 2023; FDA authorised it on 25 July 2023; FDA authorised it on 23 August 2023.

Who is the marketing authorisation holder for VARENICLINE in United States?

ZYDUS holds the US marketing authorisation.