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FDA to decide on Brilinta by July

Nikhil Kumar
Friday 04 February 2011 20:00 EST
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US regulators have set a deadline of 20 July for deciding whether to give the go-ahead to Brilinta, AstraZeneca's new heart drug.

Astra's shares were hit in December when it revealed that the US Food and Drug Administration had failed to approve the new treatment.

Yesterday, the pharmaceuticals giant said that, instead of opting for a shorter, two-month delay, the FDA had gone for a longer review, pushing Brilinta's US launch to the second half of the year. The drug, a blood thinner, is the UK group's answer to Plavix, which is manufactured by Sanofi-Aventis and Bristol-Myers Squibb and is the world's second-biggest-selling drug, with sales of more than $9bn (£5.6bn) a year.

Brilinta has already been approved in Europe, where it will be sold as Brilique.

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