Brilinta FDA Approval History
FDA Approved: Yes (First approved July 20, 2011)Brilinta
Brand name: Brilinta
Generic name: ticagrelor
Dosage form: Tablets
Treatment for: Acute Coronary Syndrome, Coronary Artery Disease, Cardiovascular Risk Reduction
(ticagrelor) is a P2Y12
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).
Development Timeline for Brilinta
|Jun 1, 2020|| Brilinta Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease|
|Sep 3, 2015|| FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack|
|Mar 30, 2015|| FDA Approves New Crushing Option for the Administration of Brilinta|
|Jul 20, 2011|| FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes|
|Feb 4, 2011||US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)|
|Jan 21, 2011||AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets)|
|Dec 17, 2010||AstraZeneca Receives Complete Response Letter From US FDA For Brilinta (ticagrelor Tablets)|
|Sep 15, 2010||US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application|
|Jul 29, 2010||FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes|
|Nov 19, 2009||AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent|
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