How Long Has Farxiga Been on the Market? Since 2014

Farxiga is the brand name for dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor made by AstraZeneca. It is not the same drug as canagliflozin (Invokana) or empagliflozin (Jardiance), though all three belong to the same class and share overlapping label warnings. Dapagliflozin also appears in combination products such as Xigduo XR (with metformin) and Qtern (with saxagliptin), which are not the focus of this page.

Direct answer: The FDA first approved Farxiga on January 8, 2014 for type 2 diabetes, then added heart failure regardless of ejection fraction (May 2020, expanded August 2023) and chronic kidney disease at risk of progression (April 2021). Each of these three indications rests on a distinct FDA-reviewed outcome trial rather than on a single broad cardiovascular claim, which is the detail most generic drug summaries omit and the reason the same molecule carries different eGFR rules depending on which condition it is prescribed for.

The question this page actually answers

A drug fact sheet can tell you the approval dates. The more useful question for a prescriber or patient is: which of Farxiga's three indications is backed by a dedicated outcome trial in that specific population, and which parts of the label are inherited class-wide safety language rather than dapagliflozin-specific findings? That distinction changes how much weight a given warning or benefit claim should carry, and it is the organizing idea for the rest of this page.

Original approval: type 2 diabetes (January 2014)

The FDA approved dapagliflozin 5 mg and 10 mg tablets on January 8, 2014, as an adjunct to diet and exercise in adults with type 2 diabetes, according to FDA approval records. This made it the second SGLT2 inhibitor to reach the U.S. market, after canagliflozin.

The agency had previously issued a complete response letter for dapagliflozin, delaying approval while it reviewed cancer signals seen in early trial data (Drugs@FDA application history). The FDA ultimately concluded that the numerical imbalance in bladder cancer cases did not establish a causal relationship, and that language was carried in the label as a precaution rather than a boxed warning. The 2014 approval program is generally described as including several thousand patients across dozens of trials showing HbA1c reduction and modest weight loss versus placebo; exact per-trial figures vary by study and should be confirmed against the specific publication before being quoted as a single number.

DECLARE-TIMI 58: why the label did not become a broad cardiovascular claim

AstraZeneca ran a large cardiovascular outcomes trial (DECLARE-TIMI 58) in patients with type 2 diabetes who either had established atherosclerotic disease or multiple risk factors. Published reporting on this trial describes a split result: dapagliflozin did not significantly reduce the composite of major adverse cardiovascular events versus placebo, but it did significantly reduce the composite of cardiovascular death or heart failure hospitalization, and it showed a renal protective signal consistent with earlier SGLT2 inhibitor trials. Because this program's evidence is described here from secondary summaries rather than a verified primary citation, readers who need the exact hazard ratios and confidence intervals should pull them directly from the original New England Journal of Medicine publication rather than relying on this page.

That split result is the likely reason AstraZeneca did not pursue a general cardiovascular risk-reduction indication for diabetes patients and instead ran separate, dedicated outcome trials in heart failure and kidney disease populations. Those two trials are what produced Farxiga's second and third indications.

Heart failure indication: DAPA-HF and the 2020 approval

On May 5, 2020, the FDA approved Farxiga for heart failure with reduced ejection fraction, regardless of diabetes status, based on the DAPA-HF trial. This was the first SGLT2 inhibitor approval for heart failure in patients without diabetes. Reported trial data describe a meaningful reduction in the composite of worsening heart failure events or cardiovascular death, with benefit that appeared consistent whether or not patients had diabetes. Precise effect sizes, confidence intervals, and the number needed to treat should be verified against the primary DAPA-HF publication before being cited in patient-facing material, since this draft is not treating the inherited citation as confirmed.

Chronic kidney disease indication: DAPA-CKD and the 2021 approval

The FDA expanded the label on April 22, 2021 to cover chronic kidney disease at risk of progression, again independent of diabetes status, according to FDA approval records. The supporting trial, DAPA-CKD, enrolled patients across a range of kidney function and was reportedly stopped early for efficacy at an interim analysis, with a large relative risk reduction in a composite renal and cardiovascular death endpoint. As with the heart failure trial, the exact percentages and confidence intervals reported in secondary sources for this page have not been independently confirmed against the primary literature and should be checked before use in clinical communication.

This is the indication that matters most for the eGFR question below: DAPA-CKD included patients with substantially reduced kidney function, which is why the current label treats CKD and heart failure differently from diabetes when it comes to how low a patient's eGFR can be before starting the drug.

Broadened heart failure label: full ejection-fraction spectrum (2023)

In August 2023, the FDA updated the label to cover heart failure across the full ejection-fraction spectrum, removing the earlier restriction to reduced ejection fraction. This followed a second heart failure outcomes trial (DELIVER) in patients with mildly reduced or preserved ejection fraction, which reportedly showed a significant reduction in the same type of composite endpoint used in DAPA-HF. Heart failure with preserved ejection fraction had few effective drug options before this class of trials, which is part of why the 2023 update mattered clinically, not just administratively.

Post-market safety communications

The FDA has issued several drug safety communications that apply to dapagliflozin, some specific to it and some applying to the SGLT2 inhibitor class as a whole:

• Diabetic ketoacidosis (2015). The FDA warned that SGLT2 inhibitors, including Farxiga, can cause ketoacidosis, sometimes with only modestly elevated blood glucose (euglycemic DKA) according to an FDA drug safety communication. This warning is class-wide, not unique to dapagliflozin.
• Kidney function warnings strengthened. The FDA strengthened kidney-related warnings for canagliflozin and dapagliflozin after reviewing post-market reports of acute kidney injury according to an FDA drug safety communication.
• Fournier's gangrene (2018). The FDA added a warning about necrotizing fasciitis of the perineum for the SGLT2 inhibitor class after identifying rare post-market cases, including cases in dapagliflozin users according to an FDA drug safety communication. This is described in FDA materials as rare; it is not a boxed warning.
• Bladder cancer language. The bladder-cancer precaution present at initial approval was later softened after longer-term follow-up data did not support a causal association, though readers should confirm the current label text directly rather than rely on a summary of a prior revision.
• Amputation. The boxed warning for lower-limb amputation that appears on the canagliflozin label has not applied to Farxiga. This is a genuine difference between two drugs in the same class, not an oversight, and it is worth stating plainly because patients sometimes assume all SGLT2 inhibitors carry identical warnings.

What the current label actually restricts

As of the most recent labeling on file, Farxiga carries three indications: type 2 diabetes, heart failure across the full ejection-fraction range, and CKD at risk of progression, each dosed at 10 mg once daily, with a 5 mg starting option used mainly for tolerability (per current FDA-approved prescribing information). Contraindications include severe hypersensitivity and use in patients on dialysis. The label restricts initiation below an eGFR of 25 mL/min/1.73 m² for the diabetes indication specifically, but does not impose that same floor for the heart failure or CKD indications, reflecting that the CKD outcome trial enrolled patients down to that filtration level and found renal benefit persisted there.

Warnings and precautions include diabetic ketoacidosis, volume depletion, urosepsis and pyelonephritis, hypoglycemia when combined with insulin or sulfonylureas, necrotizing fasciitis of the perineum, and genital mycotic infections. Anyone with symptoms suggesting DKA (nausea, vomiting, abdominal pain, unusual fatigue, difficulty breathing) or signs of a rapidly spreading perineal infection (severe pain, swelling, fever) should seek urgent care rather than waiting for a routine follow-up, regardless of glucose readings, since euglycemic DKA can occur with near-normal blood sugar.

Where this drug fits against other SGLT2 inhibitors

Canagliflozin reached the market first but carries the amputation and fracture warnings tied to its own outcome trial. Empagliflozin has a cardiovascular mortality reduction claim from its own outcomes trial that dapagliflozin does not carry, because DECLARE-TIMI 58 did not meet a MACE endpoint. Dapagliflozin is distinguished by having pursued dedicated, standalone outcome trials for heart failure and CKD rather than relying on subgroup findings from its diabetes cardiovascular trial. Ertugliflozin was approved for diabetes but its own outcomes trial did not demonstrate cardiovascular superiority, and no additional indications have followed. These are meaningful clinical differences between drugs in the same class, not interchangeable footnotes, and a patient switched from one SGLT2 inhibitor to another should not assume identical evidence supports both uses.

What is established, what is plausible, and what is not established

Established by FDA action: three distinct indications (diabetes, heart failure across the EF spectrum, CKD at risk of progression), each supported by its own outcome trial reviewed by the agency; no boxed warning currently on the Farxiga label; a class-wide DKA warning that applies to dapagliflozin.

Plausible but requiring verification of exact magnitude: the specific percentage risk reductions reported for DAPA-HF, DAPA-CKD, and DELIVER are widely cited in secondary sources, but this draft has not confirmed the exact statistics against a verified primary citation, so specific numbers should be checked in the original trial publications before being used in clinical or patient communication.

Not established: any pediatric indication, any type 1 diabetes indication in the U.S. (the EMA has approved dapagliflozin, marketed as Forxiga, for type 1 diabetes in Europe, which is a different regulatory jurisdiction and does not apply to the U.S. label), and any individualized dosing or eGFR cutoff for a specific patient, which requires the prescriber's own assessment rather than this summary.

A framework for reading which Farxiga indication applies

Because the three indications carry different trial populations and different eGFR rules, a reader trying to understand "does this apply to my situation" benefits from separating the questions rather than reading the label as one undifferentiated block.

How to use this table: if a reader or clinician is deciding whether an eGFR value is a barrier to starting or continuing Farxiga, the answer depends entirely on which indication is being treated. A diabetes-only patient with an eGFR near 25 faces a different label recommendation than a CKD or heart failure patient at the same eGFR. This distinction is easy to miss because most consumer drug summaries describe eGFR restrictions as if they applied uniformly across the whole label. They do not. Any dosing or initiation decision at borderline kidney function should be made by the prescribing clinician using the full label and the patient's clinical picture, not by matching a single number against this table.

Common reader questions

When was Farxiga first FDA approved? January 8, 2014, for type 2 diabetes as an adjunct to diet and exercise, according to FDA approval records.

Is Farxiga approved for heart failure without diabetes? Yes. The May 2020 approval and the 2023 expansion both apply regardless of diabetes status.

Does Farxiga carry a boxed warning? No. The amputation boxed warning applied to canagliflozin has not been added to the Farxiga label.

Can Farxiga be used at low kidney function? The diabetes indication advises against starting therapy below an eGFR of 25 mL/min/1.73 m². The heart failure and CKD indications do not carry that same eGFR floor in the label, because the CKD outcome trial enrolled patients down to that level. This is a clinical decision for the prescribing physician, not a self-assessment.

Is Farxiga approved for type 1 diabetes in the United States? No. It is not FDA-approved for type 1 diabetes in the U.S., largely because of ketoacidosis risk in that population. A related indication exists under a different regulator in Europe, which does not change the U.S. label.

Does insurance cover Farxiga? Coverage depends on the specific plan, the indication being treated, and formulary rules that change over time. Readers should verify current coverage, prior authorization requirements, and any manufacturer savings program directly with their insurer and pharmacy rather than relying on a general statement here.

When to seek urgent care

Anyone taking Farxiga who develops signs of ketoacidosis (persistent nausea, vomiting, abdominal pain, unusual fatigue, trouble breathing) should seek urgent evaluation even if a home glucose reading looks normal, because SGLT2 inhibitors can cause euglycemic DKA. Severe pain, swelling, or redness in the genital or perineal area with fever warrants emergency evaluation for necrotizing infection. New or worsening shortness of breath, swelling, or weight gain in a patient being treated for heart failure should be reported to the treating clinician promptly rather than waiting for a scheduled visit.

References

2. U.S. Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs, Farxiga (dapagliflozin), application overview. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202293