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FDA approves Janssen’s Invokamet XR


SILVER SPRING, Md. — The Food and Drug Administration has approved Janssen Pharmaceuticals’ Invokamet XR, a once-daily, extended-release combination therapy of Invokana (canagliflozin) and metformin, the company announced Wednesday. The drug is indicated as a first-line treatment to improve blood glucose control in adults with Type 2 diabetes alongside diet and exercise. 


“The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes,” Janssen VP medical affairs Dr. Paul Burton said. “Our Invokana portfolio now offers physicians even more choices for helping patients improve control of A1C levels and other important health measures, with numerous dosing options for monotherapy and for combination therapy with both metformin and metformin XR.”


Invokamet XR is available in 50-, 150-, 500- and 1000-mg dosage strengths. It contains a boxed warning for lactic acidosis, which is a rare but serious complication that can be caused by metformin accumulation. 


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