US, EU Regulators Ban GSK's Avandia In Most Cases

Law360, New York (September 23, 2010, 12:04 PM EDT) -- Drug regulators in the U.S. and Europe said Thursday that they would drastically restrict availability of GlaxoSmithKline PLC's diabetes medication Avandia in response to evidence that the drug could cause heart complications in patients.

The U.S. Food and Drug Administration said it would limit the use of the drug to patients with type 2 diabetes who cannot control the disease on other medications, while the European Medicines Agency said it would completely suspend sales of Avandia.

The FDA ordered GSK to undertake a restricted access program...
To view the full article, register now.