Dapagliflozin (Farxiga) UGT1A9 Metabolism and FDA Label Status
Farxiga is FDA-approved, not in shortage, and patent-protected through 2028+, so compounded dapagliflozin copies are not legal under current federal law.
Dapagliflozin: Regulatory History
7 source-based articles maintained by the HealthRX.com Editorial Team.
7articles
4topic areas covered
May 26, 2026latest review
Dapagliflozin: Regulatory History library
Showing 7 of 7 clinical reviews.
Dapagliflozin Metabolism, UGT1A9 Pathway and FDA Label
Dapagliflozin is metabolized mainly via UGT1A9 glucuronidation, per the FDA label. Covers approved indications, 10 mg dosing, and global regulatory status.
Farxiga (Dapagliflozin) FAERS Safety Signals: Post-Market Surveillance Data
A clinical review of dapagliflozin (Farxiga) safety signals reported to the FDA Adverse Event Reporting System (FAERS), including DKA, Fournier gangrene, UTI, and volume depletion findings from post-market surveillance.
Farxiga EMA vs FDA Approach: How Two Regulators Evaluated Dapagliflozin Differently
A detailed comparison of how the FDA and EMA reviewed, labeled, and post-market surveilled dapagliflozin (Farxiga/Forxiga), including approved indications, safety requirements, and post-approval commitments.
Farxiga Pipeline and Next-Gen: FDA Approvals, Label Updates, and What's Coming
A comprehensive review of dapagliflozin (Farxiga) regulatory history, current FDA-approved indications, post-market safety surveillance, and emerging pipeline uses backed by primary clinical trial data.
Farxiga Prescribing Information: 2020-2026 Label Updates
Farxiga's FDA label expanded three times since 2020, adding HFrEF, chronic kidney disease, and broader heart failure indications. See the full regulatory timeline.
How Long Has Farxiga Been on the Market? Since 2014
Farxiga won FDA approval January 8, 2014 for type 2 diabetes, then added heart failure (2020) and chronic kidney disease (2021) indications.