Drugs

FDA Flags SK Life Science’s Xcopri TV Ad as Misleading

FDA has issued an untitled letter to SK Life Science, raising concerns over a direct-to-consumer television advertisement for its seizure medication Xcopri (cenobamate tablets). According to the just-posted letter, CDER Office of Prescription Drug Promotion (OPDP) determined that the TV ad, titled “Road to Reduction XCOPRI DTC Commercial,” is false or misleading. The agency said the ad misbrands Xcopri, making its distribution a violation of federal law.

Xcopri, approved by the FDA for the treatment of partial-onset seizures in adults, carries a boxed warning for serious risks, including severe hypersensitivity reactions and potential cardiac effects. The FDA letter highlighted multiple omissions in the advertisement. While the ad mentions some risks associated with Xcopri, it fails to fully disclose the potential for liver injury and serious heart-related side effects, including QT shortening, as detailed in the FDA-approved prescribing information and medication guide. The ad also inadequately communicates critical instructions for patients experiencing allergic reactions or suicidal thoughts, the agency said.

The letter also noted that the ad’s major statement does not properly present warnings concurrently in both audio and text, a requirement for TV ads promoting prescription drugs.

The FDA has requested that SK Life Science address the violations immediately. The company must submit a written response within 15 working days, detailing how it plans to discontinue or correct the misleading promotional materials.

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