Farxiga

Lowers the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV)…. NDA 202293, held by Astrazeneca AB. Dapagliflozin.

As of Nov 13, 2026, NDA 202293 (Farxiga), held by Astrazeneca AB, was first approved by FDA on Jan 8, 2014, with 23 approved supplements and 1 published complete response letter.

First approved: Jan 8, 2014
Review: Standard
Supplements approved: 23
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

FARXIGA (dapagliflozin) is indicated:

To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors.
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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Jun 12, 2024	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
May 8, 2023	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 30, 2021	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 5, 2020	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Oct 18, 2019	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 22, 2019	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 20, 2017	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 11, 2015	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 8, 2014	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jan 17, 2012	DapagliflozinClinical, Labeling	Approved

Products

2 strengths and forms


Farxiga5MG · tablet;oral	Dapagliflozin	RxReference drug
Farxiga10MG · tablet;oral	Dapagliflozin	RxReference drug

All 24 submissions, including labeling and manufacturing supplements


Jun 3, 2026	Supplement 35Labeling · Standard review	Approved	Label Letter
Jun 12, 2024	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Sep 12, 2023	Supplement 30Labeling · Standard review	Approved	Letter Label
May 8, 2023	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Feb 17, 2023	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 13, 2022	Supplement 28Labeling	Approved	Label Letter
Apr 30, 2021	Supplement 24Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
May 5, 2020	Supplement 20Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Feb 3, 2020	Supplement 22Labeling · Standard review	Approved	Label Letter
Jan 24, 2020	Supplement 21Labeling	Approved	Label Letter
Oct 18, 2019	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Feb 22, 2019	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 26, 2018	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 20, 2017	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 1, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 17, 2016	Supplement 10Labeling · Standard review	Approved	Label Letter
Jun 14, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Jan 12, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 6, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 4, 2015	Supplement 8Labeling	Approved	Letter Label
Mar 11, 2015	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 8, 2014	Supplement 3Labeling · Standard review	Approved	Label Letter
Jul 31, 2014	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 8, 2014	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: FARXIGASep 23, 2025

Identifiers

Application: NDA 202293
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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