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Onglyza Gains Approval in EU

Bristol-Myers Squibb and AstraZeneca were granted marketing authorization for Onglyza from the European Commission.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Bristol-Myers Squibb and AstraZeneca were granted marketing authorization for Onglyza from the European Commission. Onglyza is indicated as a once-daily 5 mg tablet in adult patients with type 2 diabetes to improve glycaemic control in combination with metformin, sulphonylurea or thiazolidinedione, when these drugs alone, with diet and exercise, do not provide adequate glycaemic control. The marketing authorization is based on data from six Phase III registrational trials and a Phase IIIb stu...

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