The U.S. Food and Drug Administration (FDA) has issued an untitled letter to AstraZeneca regarding a television commercial for Farxiga (dapagliflozin), citing concerns that the ad presented an incomplete and potentially misleading description of the drug’s approved indications. The letter, sent by the Office of Prescription Drug Promotion (OPDP) on September 23 and published publicly on November 17, highlights the agency’s continued emphasis on accuracy and transparency in prescription drug advertising.
What Prompted the FDA’s Action?
Farxiga is approved to treat type 2 diabetes, chronic kidney disease (CKD), and heart failure (HF). However, the TV commercial in question only referenced a single benefit: reducing the risk of cardiovascular death. According to OPDP, this simplified claim failed to reflect the full clinical endpoints used to support Farxiga’s approvals.
For CKD, FDA noted that approval was based on a primary composite endpoint that included sustained eGFR decline of 50% or more, progression to end-stage kidney disease, and both cardiovascular and renal death.
For heart failure, approval was based on clinical trials assessing a composite endpoint of cardiovascular death, hospitalization for heart failure, and urgent HF visits.
Because none of these additional components were clearly communicated in the advertisement, FDA concluded that the commercial created a misleading impression about the drug’s approved indications.
A Broader Enforcement Trend
The letter to AstraZeneca comes shortly after FDA initiated its largest promotional enforcement action in more than a decade, posting over 100 warning and untitled letters to drug manufacturers within a single week. That crackdown underscored the agency’s concern about incomplete or exaggerated claims in consumer-facing promotional materials, especially in broadcast media.
In this context, the Farxiga ad serves as another example of how the agency is closely scrutinizing how companies present clinical evidence and approved product benefits. OPDP has given AstraZeneca 15 days to formally respond.
Why These Oversight Actions Matter
Accurate communication of drug benefits, risks, and approved indications is essential—not only for regulatory compliance, but for ensuring patient safety and maintaining public trust. When promotional materials omit key information about clinical endpoints, they risk oversimplifying complex benefit-risk profiles and potentially influencing treatment decisions based on incomplete facts.
For manufacturers, this case reinforces the importance of rigorous internal promotional review processes, cross-functional collaboration, and clear alignment between marketing messages and FDA-approved labeling.
At EMMA International
EMMA International partners with life-science organizations to strengthen their regulatory compliance frameworks, including review and oversight of promotional materials. Our experts support teams in interpreting FDA requirements, developing robust review processes, and ensuring that claims align with approved indications and clinical evidence.
Whether you are preparing advertising, training materials, or patient-facing communications, our team helps ensure your messaging remains compliant, accurate, and audit-ready.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Regulatory Affairs Professionals Society (RAPS). AstraZeneca Lands OPDP Untitled Letter Over Farxiga TV Ad. (November 2025).
U.S. Food and Drug Administration. Office of Prescription Drug Promotion – Untitled Letters and Enforcement Actions. (2025).
