FDA Approves First Farxiga Generics for Type 2 Diabetes

The FDA approved the first generics of dapagliflozin (Farxiga) tablets for adults with type 2 diabetes, the agency announced on Tuesday.

Generics of the SGLT2 inhibitor are indicated for glycemic control (alongside diet and exercise) and for reducing the risk of heart failure hospitalizations among patients with established cardiovascular disease or multiple cardiovascular risk factors.

Dapagliflozin was first approved in 2014 and works by reducing the reabsorption of glucose and sodium in the kidneys. The branded version has also picked up indications for glycemic control in kids with type 2 diabetes and for treating patients with heart failure and chronic kidney disease (CKD).

The drug has also shown some promise in metabolic dysfunction-associated steatohepatitis, with or without type 2 diabetes.

“The prescribing information for the generic dapagliflozin tablets includes the same contraindications, warnings, and precautions as Farxiga,” the FDA stated. “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.”

Dapagliflozin is not approved for use in type 1 diabetes, but research shows its use growing among patients with heart failure or CKD and concurrent type 1 diabetes.

Common adverse events reported in dapagliflozin trials include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Labeling also carries warnings regarding urosepsis, pyelonephritis, hypoglycemia, Fournier’s gangrene, and genital mycotic infections.

Dapagliflozin is available in 5 mg and 10 mg tablets and is taken once daily in the morning.