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WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.
The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.
A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.