Farxiga (dapagliflozin) – Think Diabetes

The FDA has approved dapagliflozin (Farxiga) for treatment of type 2 diabetes in adults, along with diet and exercise, the agency said in a statement.

The approval comes with strings, however: drugmakers Bristol-Myers Squibb and AstraZeneca must conduct six post-market studies, which include a cardiovascular outcomes trial in patients with baseline cardiovascular disease risks, a bladder cancer risk trial, an animal study looking at drug-induced urinary flow and bladder tumor promotion, two trials on risks in pediatric patients, and an enhanced pharmacovigilance program to study liver abnormalities and pregnancy outcomes.

via FDA Approves New Diabetes Drug.


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