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FDA approves J&J's Invokana to treat Type 2 diabetes

The U.S. Food and Drug Administration approved Johnson & Johnson's, Invokana, canaglifozin, tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes. 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 Pediatric Research Equity Act, PREA, including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study