Dapagliflozin First Approved: FDA Timeline Since 2014
Dapagliflozin (Farxiga) first won FDA approval on January 8, 2014 for type 2 diabetes, then expanded to heart failure in 2020 and chronic kidney disease in 2021.
22 source-based articles maintained by the HealthRX.com Editorial Team.
Showing 22 of 22 clinical reviews.
Dapagliflozin (Farxiga) first won FDA approval on January 8, 2014 for type 2 diabetes, then expanded to heart failure in 2020 and chronic kidney disease in 2021.
Dapagliflozin is contraindicated in the 2nd and 3rd trimesters due to fetal renal toxicity; insulin is the preferred option for diabetes in pregnancy.
Farxiga's core patent expires October 2026, with pediatric exclusivity possibly pushing generics to April 2027. Four ANDA filers have already challenged it.
Dapagliflozin dosing for adults 50-64: 10 mg once daily for T2D, HFrEF, HFpEF and CKD; no age-based adjustment, but check eGFR before and during treatment.
Dapagliflozin stays at 10 mg daily regardless of kidney function. Starts at eGFR ≥25; continue until dialysis or transplant. DAPA-CKD data included.
A detailed guide to Humana's formulary status for Farxiga (dapagliflozin), prior-authorization criteria, step-therapy requirements, appeal strategies, and cost-reduction options for 2024 to 2025.
A complete guide to TRICARE coverage of Farxiga (dapagliflozin) for type 2 diabetes, heart failure, and CKD, including formulary tier, prior authorization criteria, step therapy requirements, and how to appeal a denial.
A complete guide to UnitedHealthcare coverage for Farxiga (dapagliflozin), including formulary tier, prior authorization criteria, step therapy requirements, appeals, and cost-saving options for type 2 diabetes, heart failure, and CKD.
Evidence-based guide to dapagliflozin food and supplement interactions, including alcohol, high-sodium diets, diuretic herbs, and common supplements that affect SGLT2 inhibitor safety and efficacy.
Evidence-based guide to dapagliflozin (Farxiga) safety in geriatric patients 65+, covering renal considerations, hypotension risk, fracture data, drug interactions, and deprescribing strategies.
Does Farxiga (dapagliflozin) reduce appetite or change food cravings? A PharmD/MD-level review of the mechanisms, clinical trial data, and what patients can realistically expect.
A deep dive into dapagliflozin's long-term cardiovascular effects, covering DAPA-HF, DECLARE-TIMI 58, DAPA-CKD, and current prescribing guidance for HFrEF, HFpEF, and CKD populations.
Farxiga dosing starts at 5 mg once daily, increasing to 10 mg max based on tolerability. Same protocol applies ages 18-29, no age adjustment needed.
Dapagliflozin (Farxiga) is not FDA-approved for prediabetes, but emerging trial data suggest it may reduce diabetes progression in high-risk patients. Learn what the evidence shows, how clinicians use it off-label, and what alternatives exist.
A guide to dapagliflozin (Farxiga) hair loss and skin changes, including genital mycotic infections, rash incidence from clinical trials, and what to do if symptoms appear.
A clinician-level review of how dapagliflozin (Farxiga) affects liver enzymes, hepatic steatosis, and fibrosis markers, with primary-literature citations and dosing guidance for patients with hepatic impairment.
A clinical deep-dive into how dapagliflozin (Farxiga) affects mental health, mood, depression risk, and quality of life. Covers DAPA-HF, DAPA-CKD, and emerging mechanistic data with physician-level citations.
Evidence-based guide to muscle preservation strategies for patients on Farxiga (dapagliflozin), covering the mechanistic rationale, clinical trial data, and actionable co-interventions to protect lean mass.
A clinician-grade breakdown of dapagliflozin (Farxiga) pharmacokinetics covering absorption, distribution, metabolism, excretion, and real-world dosing implications backed by FDA label data and primary literature.
Stopping Farxiga (dapagliflozin) can trigger fluid retention, blood sugar rebound, and worsening heart failure within days. This evidence-based guide covers the mechanism, timelines, clinical trial data, and how to stop safely.
A guide to how dapagliflozin (Farxiga) affects sexual function in men and women with type 2 diabetes, heart failure, and CKD, including trial data, mechanistic explanations, and clinical management of genital mycotic infections.
Dapagliflozin (Farxiga) has no FDA-labeled taper, but stopping removes diabetes, heart failure or kidney protection. Withhold it for 3 days before surgery.