Regulatory PathRegulatory requirements compared

Active substances

Phentermine + Topiramate

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
QSYMIAEQ 3.75MG BASE;23MG; EQ 7.5MG BASE;46MG; EQ 11.25MG BASE;69MG; EQ 15MG BASE;92MGcapsule, extended release · oralVIVUS LLCPrescription17 Jul 2012
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MG; EQ 7.5MG BASE;46MG; EQ 11.25MG BASE;69MG; EQ 15MG BASE;92MGcapsule, extended release · oralACTAVIS LABS FL INCPrescription25 Jun 2024
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATEEQ 3.75MG BASE;23MG; EQ 7.5MG BASE;46MG; EQ 11.25MG BASE;69MG; EQ 15MG BASE;92MGcapsule, extended release · oralDR REDDYS LABS SAPrescription12 Jun 2025

EMA European Union — centrally authorised medicines

Qsiva Vivus BV · Refused

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPHENTERMINE-TOPIRAMATE ER 11.25-69 MG CAPSULE$3.09074per EA23 Sep 2026
US NADACPHENTERMINE-TOPIRAMATE ER 15-92 MG CAPSULE$2.84725per EA23 Sep 2026
US NADACPHENTERMINE-TOPIRAMATE ER 3.75-23 MG CAPSULE$2.98584per EA23 Sep 2026
US NADACPHENTERMINE-TOPIRAMATE ER 7.5-46 MG CAPSULE$3.0564per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.