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Diabetes Drug Candidate Appears Safe: FDA

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A potentially important diabetes medication called Onglyza appears to be free from heart-related side effects seen in similar treatments, according to U.S. Food and Drug Administration briefing documents posted online.

An FDA panel of outside experts will meet Wednesday to review safety data on the drug, the Associated Press reported. The panel will then make a recommendation on whether the drug should be approved for use in the United States.

The FDA, which generally follows the advice of its expert panels, could make a decision about Onglyza by the end of April.

Bristol-Myers Squibb and partner AstraZeneca are seeking approval to market Onglyza to reduce blood sugar levels in patients with type 2 diabetes, the AP reported.

Studies conducted by the companies indicate the level of heart attacks, deaths and other cardiovascular problems appeared well within new FDA safety limits, the agency said in the briefing documents.

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