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FDA approves AstraZeneca blood thinner expected to compete with blockbuster Plavix
WASHINGTON (AP) ' Federal health regulators are approving a long-awaited blood thinner from AstraZeneca PLC that will compete with the blockbuster pill Plavix.
The Food and Drug Administration said it approved Brilinta to reduce heart attack and death in patients with clogged arteries. The drug is designed to be used in combination with low-dose aspirin. The FDA twice delayed making a decision on the drug last year in September and again in December.
In company trials, patients taking Brilinta had fewer heart problems than those taking Plavix, which is the second-best selling drug in the world.
However the drug's label will include a boxed warning that it can cause bleeding side effects. The label also warns doctors that Brilinta should not be used with high-dose aspirin, which lessened its effectiveness in clinical trials.