FDA Approves Generic Version of Ticagrelor

On Sept. 4, the U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research approved a "first generic" Ticagrelor Tablet — 60 mg and 90 mg doses — for post-acute coronary syndrome management.

"First generics" are the first approval by the FDA which permits a manufacturer to market a generic drug product in the U.S. According to the FDA, each year several generic alternatives are approved, which in turn creates more affordable treatment options for patients.

The FDA approved AstraZeneca's Brilinta (ticagrelor) for use in 60 mg doses in September 2015.

Keywords: ACC Advocacy, Purinergic P2Y Receptor Antagonists, Acute Coronary Syndrome, Drugs, Generic, Drug Evaluation, United States Food and Drug Administration, Adenosine, Research, Tablets


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