FDA — authorised 17 July 2012
- Application: NDA022580
- Marketing authorisation holder: VIVUS LLC
- Local brand name: QSYMIA
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Phentermine-Topiramate on 17 July 2012
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 17 July 2012; FDA has authorised it.
VIVUS LLC holds the US marketing authorisation.