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GAITHERSBURG, Md. - (Mealey's) A majority of Food and Drug Administration advisers voted July 14 to keep Avandia on the market but split on whether the anti-diabetes drug made by GlaxoSmithKline PLC (GSK) should carry additional warnings about its heart risks or that its use be restricted.
Twelve out of 33 advisory committee members voted to withdraw GSK's drug. However, almost all the remaining committee members - 20 - voted to keep Avandia on the market, casting votes for three options.
Ten members voted to keep the drug on the U.S. market with additional warnings or restrictions on its prescribing. Seven committee members voted to keep Avandia on the market with additional warnings for contraindications for certain patients or for use as a second-line treatment of type 2 diabetes.
Three members voted to keep the drug on the market along with its black box warning for increased risk of ischemic cardiovascular events. One member abstained.
The vote is advisory only. The FDA will make a final determination.
[Editor's Note: Full coverage will be in the July 22 issue of Mealey's Emerging Drugs & Devices. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
For more information, call editor Tom Moylan at 610-205-1120, or e-mail him at email@example.com.