🇺🇸 Phentermine and Topiramate in United States

FDA authorised Phentermine and Topiramate on 17 July 2012

Marketing authorisations

FDA — authorised 17 July 2012

  • Application: NDA022580
  • Marketing authorisation holder: VIVUS LLC
  • Status: supplemented

FDA — authorised 25 June 2024

  • Application: ANDA204982
  • Marketing authorisation holder: ACTAVIS LABS FL INC
  • Status: approved

FDA — authorised 12 June 2025

  • Application: ANDA208175
  • Marketing authorisation holder: DR REDDYS LABS SA
  • Status: approved

FDA

  • Status: approved

Phentermine and Topiramate 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 Phentermine and Topiramate approved in United States?

Yes. FDA authorised it on 17 July 2012; FDA authorised it on 25 June 2024; FDA authorised it on 12 June 2025.

Who is the marketing authorisation holder for Phentermine and Topiramate in United States?

VIVUS LLC holds the US marketing authorisation.