Qsymia

For obesity Adults with overweight in the presence of at least one weight-related…. NDA 22580, held by Vivus LLC. Phentermine Hydrochloride; Topiramate.

As of Nov 14, 2026, NDA 22580 (Qsymia), held by Vivus LLC, was first approved by FDA on Jul 17, 2012, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 17, 2012
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

QSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Sep 13, 2024	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 24, 2022	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 17, 2012	Original applicationNew combination · Standard review	Approved	Review Summary Review Other Letter

Products

4 strengths and forms


QsymiaEQ 3.75MG BASE;23MG · capsule, extended release;oral	Phentermine Hydrochloride; Topiramate	RxReference drug
QsymiaEQ 7.5MG BASE;46MG · capsule, extended release;oral	Phentermine Hydrochloride; Topiramate	RxReference drug
QsymiaEQ 11.25MG BASE;69MG · capsule, extended release;oral	Phentermine Hydrochloride; Topiramate	RxReference drug
QsymiaEQ 15MG BASE;92MG · capsule, extended release;oral	Phentermine Hydrochloride; Topiramate	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Jun 29, 2026	Supplement 32REMS	Approved	Label Letter
Mar 6, 2026	Supplement 31Labeling	Approved	Label Letter Medication Guide
Jul 11, 2025	Supplement 29REMS	Approved	Letter Label
Nov 19, 2024	Supplement 26REMS	Approved	Letter Label
Sep 13, 2024	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 6, 2024	Supplement 24REMS	Approved	Letter
Jun 28, 2023	Supplement 23Labeling · Standard review	Approved	Letter Label
May 9, 2023	Supplement 22REMS	Approved	Letter
Jun 24, 2022	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 8, 2022	Supplement 20REMS	Approved	Review Letter
Mar 31, 2021	Supplement 19REMS	Approved	Letter Label
Oct 19, 2020	Supplement 17Labeling · Standard review	Approved	Label Letter
Mar 23, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Jan 27, 2017	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 26, 2014	Supplement 12Labeling · Standard review	Approved	Letter Label
Sep 26, 2014	Supplement 11Labeling · Standard review	Approved	Letter Label
Sep 26, 2014	Supplement 10REMS	Approved	Label Letter
Oct 17, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 24, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 16, 2013	Supplement 4REMS	Approved	Letter Label
Mar 19, 2013	Supplement 5Manufacturing · Standard review	Approved	Label
Nov 1, 2012	Supplement 1REMS	Approved	Letter Label
Jul 17, 2012	Original applicationNew combination · Standard review	Approved	Review Summary Review Other Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: QSYMIAMay 22, 2019

Identifiers

Application: NDA 22580
Drugs@FDA: Overview at FDA
Company: Vivus

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters