Albiglutide FDA review date now April 2014
GSK has announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide (proposed name Syncria), an investigational once-weekly treatment for adult patients with Type 2 Diabetes, has been extended by three months to 15 April 2014 to provide time for a full review of information submitted by GSK in response to FDA requests. GSK announced the submission of a Biologics Licence Application to the FDA for albiglutide on 14 January 2013 and this was followed by the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) on 7 March 2013. The EMA filing is progressing to schedule. Albiglutide is not approved for use anywhere in the world.
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