Nonetheless lifetime of the brand new Wegovy semaglutide tablets on a white background. Its a prescription drugs used with a decreased calorie weight loss program and .and bodily exercise.
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The Meals and Drug Administration stated Novo Nordisk‘s TV commercial for its newly launched Wegovy pill for obesity included “false or deceptive” claims concerning the drugs’s skills and advantages to sufferers.
In a letter to Novo dated Feb. 5, the FDA stated the ad misbrands the oral drug, making its distribution a violation of federal regulation. The company requested that the drugmaker take quick motion to deal with the violations, which may embody ceasing all advertisements containing deceptive claims.
In an announcement Monday, Novo Nordisk confirmed that it acquired the letter and clarified that the ad has been operating because the pill’s launch, however shouldn’t be the corporate’s Tremendous Bowl spot.
“We take all regulatory suggestions severely and are within the means of responding to the FDA to deal with their considerations concerning the commercial’s presentation,” Liz Skrbkova, Novo’s head of U.S. media and stakeholder relations, stated within the assertion.
It provides to the mounting hurdles the Danish drugmaker is going through because it scrambles to win again market share from chief rival Eli Lilly and cheaper compounded copycats within the booming GLP-1 market.
The corporate’s Wegovy pill is vital to these efforts. It was the first-ever GLP-1 pill for obesity to enter the market in January, and Novo final week stated greater than 170,000 American sufferers are already taking the drug.
Bloomberg first reported on the FDA letter on Monday.
Within the letter, the FDA stated Novo’s ad misleadingly suggests its pill affords superior advantages to different permitted GLP-1 weight reduction medication. The company stated phrases used within the spot, together with “reside lighter” and “a method ahead,” indicate better weight reduction than different remedies and added advantages past that, regardless of no proof to assist these claims.
The ad’s statements “misleadingly indicate advantages past bodily weight reduction similar to emotional reduction, decreased psychological burden, hope, or path for sufferers’ lives, positioning the drug as an answer to broader life challenges moderately than a therapy for a particular situation, when this has additionally not been demonstrated,” the FDA stated within the letter.
The FDA additionally flagged the ad for failing to correctly current threat data in each audio and textual content, a requirement for tv drug promoting.
Additionally on Monday, Novo Nordisk sued Hims & Hers, asking the court docket to cease the telehealth firm from mass advertising compounded variations of its Wegovy pill and injections.
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