Drugs

Esperion TV Spot for Nexlizet False, Misleading: FDA

The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer connected TV broadcast ad for Esperion Therapeutics’ Nexlizet (bempedoic acid and ezetimibe) tablets for oral use is false and misleading. A just-released 12/19/2025 Notice of Violation says the ad’s claims and presentations falsely suggest that bempedoic acid is the only non-statin approved by FDA to lower bad cholesterol and reduce the risk of heart attack in statin-intolerant patients.

“Specifically,” OPDP says, “certain PCSK9 inhibitors are also FDA approved to lower LDL cholesterol and reduce the risk of major adverse cardiovascular events such as heart attack, and the indications for these products do not limit their use to adult patients who are either statin tolerant or intolerant.”

The letter says the ad is misleading because of the compelling and attention-grabbing visuals during the presentation of the major statement, which interfere with the comprehension of the major statement.

Esperion was told to respond with a list of all Nexlizet promotional communications that contain representations like those described in the letter and explaining the company’s plan to discontinue such communications or cease distribution of Nexlizet.

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