Invokamet Xr

For type 2 diabetes mellitus. NDA 205879, held by Janssen Pharms. Canagliflozin; Metformin Hydrochloride.

As of Nov 13, 2026, NDA 205879 (Invokamet Xr), held by Janssen Pharms, was first approved by FDA on Sep 20, 2016, with 15 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2016
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Dec 18, 2024	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Medication Guide Label Letter
Aug 18, 2020	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2020	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 29, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 2, 2018	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 20, 2016	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Invokamet Xr50MG;500MG · tablet, extended release;oral	Canagliflozin; Metformin Hydrochloride	RxReference drug
Invokamet Xr50MG;1GM · tablet, extended release;oral	Canagliflozin; Metformin Hydrochloride	RxReference drug
Invokamet Xr150MG;500MG · tablet, extended release;oral	Canagliflozin; Metformin Hydrochloride	RxReference drug
Invokamet Xr150MG;1GM · tablet, extended release;oral	Canagliflozin; Metformin Hydrochloride	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 26Labeling	Approved	Label Medication Guide Letter
Aug 11, 2026	Supplement 25Labeling · Standard review	Approved	Label Letter
Dec 18, 2024	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Medication Guide Label Letter
Aug 23, 2024	Supplement 22Labeling · Standard review	Approved	Label Letter
Jan 19, 2024	Supplement 20Labeling · Standard review	Approved	Letter Label
Jul 5, 2023	Supplement 19Labeling · Standard review	Approved	Letter Label
Oct 13, 2022	Supplement 18Labeling	Approved	Label Letter
Aug 18, 2020	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2020	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 24, 2020	Supplement 14Labeling	Approved	Label Letter
Oct 29, 2018	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 26, 2018	Supplement 9Labeling	Approved	Letter Label
Jan 2, 2018	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 11, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Jul 25, 2017	Supplement 5Labeling	Approved	Letter Label
Sep 20, 2016	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 205879
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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