Januvia™ (Sitagliptin Phosphate) Receives Approval in Mexico

Approval of Januvia in Mexico Marks the First DPP-4 Inhibitor, a New Class of Oral Type 2 Diabetes Medicines, to be Approved in the World. Merck & Co., Inc. announced today that Januvia™ (sitagliptin phosphate) has been approved in Mexico as an oral, once-daily medicine for type 2 diabetes.

This approval is the first in the world for a new class of oral drugs for type 2 diabetes (dipeptidyl peptidase-4 [DPP-4] inhibitors) that enhances the body’s own ability to lower blood sugar (glucose) when it is elevated. The mechanism of action of DPP-4 inhibitors is distinct from that of any currently available class of glucose-lowering agents.

Mexico is the first country in the world to grant regulatory approval to Januvia. Januvia remains an investigational product in the United States. The New Drug Application (NDA) for Januvia has been accepted for standard review by the U.S. Food and Drug Administration (FDA), and Merck expects FDA action on the NDA by mid-October. The Company is also moving forward as planned with regulatory filings in various countries around the world.

Januvia™ is the proposed trademark for MK-431 (sitagliptin phosphate).

Merck & Co., Inc.
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