FDA accepts NDA for extended-release Janumet for type 2 diabetes

Merck announced that the New Drug Application (NDA) for its investigational extended-release formulation of Janumet (sitagliptin/metformin HCI) for type 2 diabetes has been accepted for standard review by the FDA. The extended-release formulation of Janumet combines the DPP-4 inhibitor, sitagliptin, which is the active component of Merck's Januvia, with metformin extended release, a commonly-prescribed medication for type 2 diabetes, into a single tablet.

The currently approved immediate-release formulation of Janumet is indicated, as an adjunct to diet and exercise and to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.

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