EMA suspends while FDA severely restricts Avandia after data review
This article was originally published in Scrip
Executive Summary
The European Medicines Agency (EMA) has suspended the marketing authorisation for all rosiglitazone-containing products, but not revoking approval. These medicines will no longer be available in Europe in the next few months. The decision followed months of review of data on GlaxoSmithKline's Avandia and its link to cardiovascular safety issues.