The FDA has approved the first generic drugs, dapagliflozin (Farxiga) tablets, for adults with type 2 diabetes. announced the agency On Tuesday.
Generics of SGLT2 inhibitors are indicated for glycemic control (with diet and exercise) and to reduce the risk of heart failure hospitalization in patients with established heart 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 also has indications for glycemic control in children with type 2 diabetes and the treatment of patients with heart failure and chronic kidney disease (CKD).
The drug has also shown some promise in steatohepatitis associated with metabolic dysfunction, with or without type 2 diabetes.
“The determining information The generic dapagliflozin tablets include the same contraindications, warnings and precautions as Farxiga, the FDA said. Dapagliflozin is contraindicated in patients with a history of severe hypersensitivity reactions to dapagliflozin or any of the excipients. “Dapagliflozin carries warnings such as diabetic ketoacidosis and volume depletion in patients with type 1 diabetes mellitus and other ketoacidosis.”
Dapagliflozin is not approved for use in type 1 diabetes, but research suggests its use is increasing in patients with heart failure or CKD and concurrent type 1 diabetes.
Common adverse events reported in dapagliflozin trials included female genital mycotic infection, nasopharyngitis, and urinary tract infection. The labeling also contains warnings regarding urosepsis, pyelonephritis, hypoglycemia, Fournier’s gangrene, and genital mycotic infection.
Dapagliflozin is available in 5 mg and 10 mg tablets and is taken once daily in the morning.
