FDA Approves First Generic Farxiga (dapagliflozin) Tablets

The U.S. Food and Drug Administration approved the first generics of Farxiga (dapagliflozin) tablets to reduce 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 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Farxiga is sodium-glucose cotransporter 2 (SGLT2) inhibitor that works by reducing the reabsorption of glucose and sodium in the kidneys.

Type 2 diabetes is a chronic condition that occurs when the body does not use insulin well and cannot keep blood sugar at normal levels. It develops over many years and is usually diagnosed in adults. According to the Centers for Disease Control and Prevention, more than 40 million Americans have diabetes, and 90% to 95% of those individuals have type 2 diabetes.

The prescribing information for the generic dapagliflozin tablets includes the same contraindications, warnings and precautions as Farxiga. Dapagliflozin is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients. Dapagliflozin carries warnings such as diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis, and volume depletion. The most common side effects reported in the clinical trials for dapagliflozin were female genital mycotic infections, nasopharyngitis, and urinary tract infections

Healthcare providers should review the full prescribing information for complete safety and dosing information.

The FDA granted approval of dapagliflozin tablets to multiple generic drug applicants. Please check the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”) for a complete list of approvals and contact the manufacturers for information about a medicine’s availability.

Farxiga is a registered trademark of the AstraZeneca group of companies.