The FDA announced its approval of Janssen Pharmaceuticals‘ Invokana (canagliflozin) tablets, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Invokana is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose in the kidney, increases glucose excretion, and lowers blood glucose levels.

Invokana was studied as monotherapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Its safety and effectiveness was evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels and fasting plasma glucose levels along with reduced body weight and systolic blood pressure.

The FDA is requiring five postmarketing studies for Invokana: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the PREA.

Invokana tablets will be available in 100mg and 300mg strengths.

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