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Galvus Approval Delayed While FDA Reviews Safety Data

Novartis reports that there will be a three-month delay in approval for its experimental diabetes drug, Galvus, due to the FDA’s request for additional safety data.

On November 13, 2006, Novartis announced that it is submitting further data to the FDA, “meaning that the U.S. regulator’s decision on approving the product will probably come at the end of February, 2007, three months later than expected.”

Galvus is a DPP-IV inhibitor that works by enhancing the body’s own ability to lower blood sugar levels. Merck Co.’s Januvia is also a DPP-IV inhibitor, which was granted FDA approval in October 2006.

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