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AstraZeneca PLC's XIGDUO Receives Positive Opinion from CHMP for Treatment of Type 2 Diabetes

Friday, 22 Nov 2013 08:42am EST 

AstraZeneca PLC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Xigduo (dapagliflozin and metformin hydrochloride) for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapgliflozin and metformin as separate tablets. The CHMP's positive opinion will be reviewed by the European Commission, which has the authority to approve medicines for the European Union. 

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