The company will be putting aside additional monies for other investigations, including one by the U.S. attorney in Colorado into the company’s sales and promotional practices of certain products.
The troubles mount for Glaxo, and this report simply shows the costs related to a drug that the FDA has put under the microscope. As recently as 9/23/10, the FDA placed restrictions on the drug.
From the FDA release:
The U.S. Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.” Link.
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