The US Food and Drug Administration approved the first generic versions of FARXIGA (dapagliflozin) tablets, according to an agency press release. The approvals include multiple generic dapagliflozin products for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, and for improving glycemic control as an adjunct to diet and exercise.

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor that reduces the reabsorption of glucose and sodium in the kidneys. Type 2 diabetes mellitus is a chronic condition in which the body does not use insulin well and cannot maintain normal blood glucose levels and is typically diagnosed in adults. According to the Centers for Disease Control and Prevention, more than 40 million Americans have diabetes, with approximately 90% to 95% classified as type 2 diabetes.

The generic dapagliflozin tablets carry prescribing information consistent with the branded product, including the same contraindications, warnings, and precautions. Use is contraindicated in patients with a prior serious hypersensitivity reaction to dapagliflozin or any of its components. Reported safety concerns include diabetic ketoacidosis, particularly among patients with type 1 diabetes, as well as other ketoacidosis events and volume depletion. In clinical studies, the most frequently observed adverse events included female genital mycotic infections, nasopharyngitis, and urinary tract infections.

The agency approved dapagliflozin tablets from multiple generic drug applicants. Healthcare providers are encouraged to consult the Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, for details on approved products, to review the full prescribing information for comprehensive safety and dosing guidance, and to contact manufacturers for information about product availability.

Source: FDA