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FDA Wants Another "Black Box" Warning For Avandia

Law360 (October 24, 2007, 12:00 AM EDT) -- Amid growing concerns over the safety of Avandia, the U.S. Food and Drug Administration is reportedly pushing for the diabetes drug's manufacturer GlaxoSmithKline PLC to add an additional so-called “black box” warning about heart-attack risk to the label.

Officials at the agency are currently in the midst of talks with the pharmaceutical giant over the final form of the new label, which the FDA wants to include the tougher warning, the Wall Street Journal reported Wednesday, citing sources familiar with the matter.

Glaxo already agreed in...
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