FDA Approves First Generic Dapagliflozin Tablets

On April 7, 2026, the FDA granted approval to multiple generic-drug applicants for Farxiga (dapagliflozin) tablets, the first generics featuring the compound to reach the US market.1 The approvals cover two indications, the primary being reducing the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus who have either established cardiovascular disease or multiple cardiovascular risk factors. It is also an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Type 2 diabetes is a chronic condition that develops over many years, occurring when the body does not use insulin well and cannot keep blood sugar at normal levels.1 More than 40 million Americans have diabetes with 90% to 95% of that population having type 2 diabetes.

Farxiga works as a sodium-glucose cotransporter 2 inhibitor, which reduces the reabsorption of glucose and sodium in the kidneys.1 The tablets are available in 5 mg and 10 mg strengths, with bioequivalence to the reference listed drug required as a condition of approval.

What Safety and Labeling Requirements Apply to These Generic-Drug Applicants?

Farxiga is contraindicated in patients with a history of a serious hypersensitivity reaction to dapagliflozin or any of the excipients.1 Warnings include diabetic ketoacidosis in patients with type 1 diabetes mellitus and other ketoacidosis, and volume depletion. The most common side effects reported in clinical trials were female genital mycotic infections, nasopharyngitis, and urinary tract infections. Healthcare providers should review the full prescribing information for complete safety and dosing information, and manufacturers should ensure their labeling reflects the full scope of these requirements before commercialization.

The full list of approved applicants is available through the Approved Drug Products with Therapeutic Equivalence Evaluations.1 Given that approvals were granted to multiple manufacturers simultaneously, companies should anticipate a competitive launch environment and plan production schedules and market entry strategies accordingly.

How Are Recent Type 2 Diabetes Approvals Reshaping Injectable Treatment Development?

While the generic dapagliflozin approvals mark a significant moment for oral glucose-lowering therapy, the injectable insulin space is undergoing a parallel shift.2 On March 26, 2026, the FDA approved Awiqli (insulin icodec-abae) injection 700 units/mL, the only once-weekly, long-acting basal insulin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The approval is supported by the Onwards phase IIIa clinical program, which comprised four randomized, active-controlled, treat-to-target trials in approximately 2680 adults with uncontrolled type 2 diabetes.2 The program evaluated once-weekly Awiqli against daily basal insulin and demonstrated efficacy in the primary endpoint of A1C reduction across the trial program. The safety profile was consistent with the daily basal insulin class, with common adverse events including hypoglycemia, injection site reactions, and weight gain.

Awiqli is administered at a concentration of 700 units/mL using a dedicated pen injector, a delivery system designed to minimize the risk of dosing errors.2 The prescribing information includes specific guidance around pen use, dose selection, and the risk of mix-ups with other injectable products.

"Research supports weekly injectable diabetes medications can be associated with improved patient adherence," Julio Rosenstock, MD, a principal investigator for the ONWARDS trial program, stated in a press release.2 "Having a weekly basal insulin option like insulin icodec-abae may reshape insulin management in adults with type 2 diabetes, giving them a routine that feels more manageable as they work toward their blood sugar goals."

References

1. U.S. Food and Drug Administration. FDA approves first generic dapagliflozin tablets. Published April 6, 2026. Accessed April 8, 2026. http://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generic-dapagliflozin-tablets
2. Novo Nordisk A/S. Awiqli approved in the US, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. Published March 27, 2026. Accessed April 8, 2026. https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302726839.html