Brilinta

Lowers the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke. NDA 22433, held by Astrazeneca. Ticagrelor.

As of Nov 14, 2026, NDA 22433 (Brilinta), held by Astrazeneca, was first approved by FDA on Jul 20, 2011, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2011
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BRILINTA is a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of BRILINTA was established in a population with type 2 diabetes mellitus (T2DM).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below


Mar 22, 2024	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 9, 2022	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 5, 2020	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
May 28, 2020	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 3, 2019	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 3, 2015	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Other Review Letter Label
Jul 20, 2011	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Brilinta90MG · tablet;oral	Ticagrelor	RxReference drug
Brilinta60MG · tablet;oral	Ticagrelor	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


May 7, 2026	Supplement 39Labeling · Standard review	Approved	Label Letter
Nov 4, 2024	Supplement 37Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 22, 2024	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 9, 2022	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 10, 2021	Supplement 32Labeling · Standard review	Approved	Letter Label
Feb 17, 2021	Supplement 31Labeling · Standard review	Approved	Letter Label
Nov 5, 2020	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Sep 15, 2020	Supplement 30Labeling · Standard review	Approved	Label Letter
May 28, 2020	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 24, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 3, 2019	Supplement 23Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 9, 2018	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 23, 2016	Supplement 20Labeling · Standard review	Approved	Label Letter
Aug 11, 2016	Supplement 19Labeling · Standard review	Approved	Label
Jul 22, 2016	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 21, 2015	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 16, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 3, 2015	Supplement 15Efficacy (new indication or use) · Priority review	Approved	Other Review Letter Label
Jun 24, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 26, 2015	Supplement 13Labeling · Standard review	Approved	Letter Label
Jul 18, 2014	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 7, 2014	Supplement 11Manufacturing	Approved	None posted
Dec 13, 2013	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 30, 2013	Supplement 9REMS	Approved	Letter
Mar 29, 2013	Supplement 8Labeling · Standard review	Approved	Label Letter
Jan 24, 2013	Supplement 6Labeling	Approved	Label Letter
Dec 5, 2012	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 9, 2012	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 20, 2011	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22433
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