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Brilinta Approval History

  • FDA approved: Yes (First approved July 20th, 2011)
  • Brand name: Brilinta
  • Generic name: ticagrelor
  • Dosage form: Tablets
  • Company: AstraZeneca
  • Treatment for: Acute Coronary Syndrome

Brilinta (ticagrelor) is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome.

Development History and FDA Approval Process for Brilinta

Sep  3, 2015Approval FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack
Mar 30, 2015Approval FDA Approves New Crushing Option for the Administration of Brilinta
Jul 20, 2011Approval FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes
Feb  4, 2011US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)
Jan 21, 2011AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets)
Dec 17, 2010AstraZeneca Receives Complete Response Letter From US FDA For Brilinta (ticagrelor Tablets)
Sep 15, 2010US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application
Jul 29, 2010FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes
Nov 19, 2009AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent

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