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