FDA Policy/General

FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA has determined that a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) tablets is misleading and misbrands the drug. In a just-posted untitled letter, CDER Office of Prescription Drug Promotion (OPDP) takes issue with the ad, titled “Farxiga DTC TV: 45 – Places You Want to Be v2”, which promoted Farxiga for adults with chronic kidney disease (CKD) or heart failure, claiming the drug “can help you keep living life by reducing the risk of cardiovascular death.”

According to the letter, this presentation oversimplifies Farxiga’s approved benefits. In CKD patients, the drug’s approval is based on reducing the incidence of a composite endpoint: greater than 50% sustained decline in estimated glomerular filtration rate, progression to end-stage kidney disease, cardiovascular or renal death, the agency says. For heart failure, approval is based on a composite of cardiovascular death, hospitalization for heart failure, or urgent heart failure visit. The letter contends the ad failed to adequately communicate these composite endpoints, creating a misleading impression about the drug’s actual indications.

OPDP told AstraZeneca to take immediate steps to correct the violations, including ceasing distribution of misleading promotional communications. AstraZeneca has 15 working days to respond in writing, detailing all similar promotional materials and outlining a plan to address the concerns.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome