Invokamet XR (canagliflozin + metformin hydrochloride extended release) submitted to FDA for type 2 diabetes- Janssen
Janssen Research & Development has submitted to the FDA a New Drug Application (NDA) for Invokamet XR, a once-daily therapy combining fixed doses of canagliflozin and metformin hydrochloride extended release (XR) in two tablets. If approved, Invokamet XR will provide a new treatment option for adults with type 2 diabetes mellitus as an adjunctive treatment to diet and exercise to improve glycemic control.
Invokamet, the first fixed-dose combination tablet in the United States combining canagliflozin and immediate release metformin hydrochloride, received approval from the FDA in August 2014 for the treatment of adults with type 2 diabetes. The same formulation was approved by the European Commission (EC) in April 2014, under the name Vokanamet for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control.
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