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Merck’s Diabetes Drug Accepted for Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck’s NDA for Januvia has been accepted for review by the FDA. Merck expects FDA action on the NDA by mid-October. The company also is moving forward with filings in countries outside the U.S. Januvia is an investigational once-daily medicine with a novel mechanism of action for the treatment of type 2 diabetes. If approved, Januvia would potentially be the first in a new class of oral medications (DPP-4 inhibitors) that enhances the body’s own ability to lower blood sugar whe...

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