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Policy
... and Gets FDA Backing for Avandia
August 6, 2007
| A version of this story appeared in
Volume 85, Issue 32
By a vote of 22-1, an FDA advisory panel voted last week to keep GlaxoSmithKline's diabetes treatment Avandia on the U.S. market, despite safety concerns. FDA issued a safety alert regarding Avandia in May, citing data from clinical trials that indicate a "potentially significant increase" in the risk of heart attack for patients. However, FDA also cited results from other tests contradicting this data. Avandia, with worldwide sales of about $3 billion, two-thirds of which are in the U.S., is GSK's second largest selling drug.
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