By laksh5382 
Boxes of Ozempic and Vegovy, made by Novo Nordisk, are seen in a pharmacy.
Holly Adams | reuters
Novo Nordisk Asked the Food and Drug Administration on Tuesday Stop Compounding Pharmacies By rejecting and often making cheap editions About its popular weight loss injections wegovy and diabetes treatment Ozempic, arguing that the drugs are too complex for those manufacturers to make them safely.
The FDA has yet to make a final decision on whether to ban mixed versions of semaglutide, the active ingredient in Ozempic and Vegovy. In a statement, the agency said it was reviewing the petition and would respond directly to Novo Nordisk.
The move is Novo Nordisk’s latest effort Crack down on potentially harmful copies of semaglutide after 50 lawsuits were filed against several clinics, compounding pharmacies and other manufacturers over the past year. It comes as the Danish drugmaker tries to increase supplies of semaglutide to meet unprecedented demand in the US
Amid intermittent US shortages of branded drugs, patients have turned to compounded versions of semaglutide, which cost a hefty $1,000 a month before insurance and other rebates. Many health plans do not cover semaglutide for weight loss, making the combined version a more affordable option.
Compounded medications are custom-made alternatives to branded medications designed to meet a specific patient’s needs. When there is a shortage of a brand-name drug, compounding pharmacies can prepare copies of the drug if they meet FDA requirements.
Semaglutide, the active ingredient in Vegovy and Ozempic, has been in intermittent shortage over the past two years. The lowest dose of Vegovy is currently in short supply, but the drug and all other doses of Ozempic are listed as available. FDA drug shortage database,
But Novo Nordisk nominated semaglutide late Tuesday for FDA “Difficulties displayed for combination” lists, That includes complex drugs that compounders are not allowed to make, even during shortages, because they could potentially pose a safety risk.
“Semaglutide products fit this description due to their inherent complexity and the potential risks associated with attempting to mix them,” Novo Nordisk said in a statement.
The Danish drugmaker cited several risks with compounded versions of semaglutide, including unknown impurities, incorrect dosage strengths and instances where a compounded product contained no semaglutide at all.
“These medicines are inherently complex to be mixed safely, and the risks they pose to patient safety far outweigh any benefits,” Novo Nordisk said in a statement. “The purpose of this nomination is to ensure that patients receive only FDA-approved, safe and effective semaglutide products,” the company said.
FDA has were warned earlier About the risks of using mixed versions of so-called GLP-1s, such as semaglutide. It refers to a busy class of drugs that mimic hormones produced in the gut to reduce a person’s appetite and control their blood sugar.
Earlier this month, the FDA said that compounded versions of semaglutide and similar drugs could be riskier for patients because they are unapproved, meaning the agency will have to check their safety, effectiveness and quality before bringing them to market. Does not review.
In August the FDA also said reports received The number of patients taking an overdose of compounded semaglutide due to errors such as the patient taking the wrong dose of the treatment himself.
Both Vegovy and Ozempic are under patent protection in the US and abroad, and Novo Nordisk and its rivals Eli Lilly Do not supply the active ingredients in your medicines to outside groups. This is what the companies say raises questions About what some manufacturers are selling and marketing to consumers.
Tirazeptide is the active ingredient in Eli Lilly’s weight loss injection Zepbound and diabetes treatment Monjaro.
Like Novo Nordisk, Eli Lilly has filed a lawsuit against Many weight loss clinics, medical spas and compounding pharmacies have mushroomed across America over the past year.
Notably, the FDA removed tirazeptide from its shortage list in October after more than a year, although some pharmacies say they are still struggling to stock up on branded versions of that drug. A trade group representing some compounders sued the FDA, leading the agency to say it would reconsider its decision to remove tirazeptide from its deficiency list.