Quoted from http://www.reuters.com/article/idUSLDE66L1EL20100722
EU agency defers decision on Glaxo's Avandia
By Ben Hirschler
LONDON, July 22 (Reuters) - The European Medicines Agency is still reviewing GlaxoSmithKline's (GSK.L) diabetes drug Avandia, which has been linked to heart attacks, and will recommend whether or not it should stay on the market by September.
The watchdog had been expected by many analysts to give a view on the controversial drug following a meeting this week, but the agency said on Thursday its panel of experts was deferring a decision to allow time to study new data.
"The committee noted that additional new data sets have become available very recently," the agency said in a statement.
"It will assess these data in depth, together with all other available data on the benefits and risks of rosiglitazone (Avandia), to allow the finalisation of the current review by September 2010."
In the meantime, the EMA urged physicians to strictly follow current restrictions on using the diabetes pill.
The European review mirrors a separate probe into the drug by the U.S. Food and Drug Administration, which is due to make a decision on Avandia in the coming months after a U.S. advisory panel voted last week to keep it on the market but with additional warnings.
The vote came as a big relief to Glaxo, which has faced a storm of criticism over the former blockbuster medicine, as well as wave of U.S. lawsuits, most of which have now been settled.
