The FDA warning, issued on Nov. 16, stated that Seroquel sales material distributed by the company was misleading because it minimized information about certain risks contained the the drugs' labeling.
AstraZeneca said in an emailed statement that the sales material was accompanied by a copy of the FDA-approved product labeling, which includes the complete warnings and precautions.
"AstraZeneca takes FDA's letter seriously. We will work with the FDA to resolve the matter," the company said.
Seroquel, which is used to treat schizophrenia and bipolar disorder, is AstraZeneca's second best-selling drug, with sales of $2.8 billion in 2005."Source: MarketWatch