Posted from: Monday, October 05, 2015 - 04:39 PM - Present

Extended Indication and New Strength Tablet for Brilinta

September 3, 2015 – The U.S. Food and Drug Administration (FDA) approved an extended indication and a new strength tablet for Brilinta (ticagrelor), a platelet inhibitor. Previously approved by the FDA in 2011, Brilinta was indicated to decrease the risk of heart attacks, strokes, and cardiovascular-related death for patients who have acute coronary syndrome (ACS) or who have already had a heart attack. FDA’s new indication for Brilinta extends treatment beyond one year at a low dose of 60mg twice daily rather than the 90mg as it was originally approved. Brilinta labels will continue to have boxed warnings that using it may increase the risk of significant bleeding and that taking more than 100mg of aspirin per day decreases Brilinta’s effectiveness. The 60mg Brilinta tablets are scheduled to be launched in the third quarter of 2015 by AstraZeneca.

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Last Updated Friday, March 24, 2017 - 08:48 AM.