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Janumet Approval History

  • FDA approved: Yes (First approved March 30th, 2007)
  • Brand name: Janumet
  • Generic name: metformin and sitagliptin
  • Dosage form: Tablets
  • Company: Merck & Co., Inc.
  • Treatment for: Diabetes, Type 2

Janumet is a combination of the oral antihyperglycemic drugs sitagliptin and metformin indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.

Development History and FDA Approval Process for Janumet

Feb  2, 2012Approval FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience
Apr  2, 2007Approval FDA Approves Janumet for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet
Dec  1, 2006Merck Announces Janumet, the Trademark for its Investigational Combination Therapy of Sitagliptin Phosphate and Metformin for Type 2 Diabetes
Jul 31, 2006Merck Announces FDA Acceptance of NDA for MK-0431A

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