FDA
FDA clears first generic dapagliflozin tablets
On April 7, 2026, FDA approved the first generic versions of dapagliflozin tablets, marking a key step toward expanding access to a widely used therapy for adults with type 2 diabetes. The newly approved generics reference Farxiga (dapagliflozin) and are indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes with established cardiovascular disease or multiple cardiovascular risk factors, as well as to improve glycemic control as an adjunct to diet and exercise.
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers blood glucose by reducing renal reabsorption of glucose and sodium. The generic tablets are available in 5‑mg and 10‑mg strengths and carry labeling that mirrors the branded product for the approved indications and key safety warnings, including risks of ketoacidosis and volume depletion.
Notably, current generic labeling does not include certain indications held by the brand, such as chronic kidney disease, broader heart failure outcomes, or pediatric use, which remain specific to the branded product and authorized generic.
With multiple manufacturers receiving approval, the FDA action is expected to increase market competition and reduce out‑of‑pocket costs for a therapy that has become foundational in cardiometabolic care.
Source: FDA News release. (2026, April 7). FDA Approves First Generic Dapagliflozin Tablets