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British drugmaker AstraZeneca fails to clear U.S. hurdle on new drug.
Knight Ridder/Tribune Business News, October, 2004
By Ian Lyall, Daily Mail, London Knight Ridder/Tribune Business News
Oct. 7--AstraZeneca chief executive Sir Tom McKillop believes American regulators are wrong to block the launch of the company's blood-thinning drug Exanta, and slammed them for completely misjudging the "huge medical need" for the treatment.
Exanta fell at the final regulatory hurdle when the Food & Drug Administration advisory panel raised concerns about the product's possible side-effects, including a link to liver failure.
McKillop is not certain AstraZeneca will ever win approval for Exanta in the US -- the world's largest drugs market. "We cannot be optimistic of a positive recommendation or a quick turnaround of FDA opinion," he said. "Frankly, we and many...
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