LexisNexis® Legal Newsroom
Avandia Off Market In Europe; FDA To Restrict Its Use, Orders Probe of GSK Study

(Mealey's) The European Medicines Agency (EMA) on Sept. 23 recommended that the marketing authorization for GlaxoSmithKline PLC's (GSK) controversial anti-diabetes drug Avandia be suspended, and the Food and Drug Administration simultaneously said it will significantly restrict Avandia use in...

Glaxo Adds Safety Restrictions To Avandia Label

WASHINGTON, D.C. - (AP) GlaxoSmithKline PLC said Monday it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack. The Food and Drug Administration announced the changes in September as...