Ozempic And Wegovy Maker Novo Nordisk Asks FDA To Halt Production Of Compounded Fat Loss Drugs Due To Their 'Inherent Complexity'
Ozempic And Wegovy Maker Novo Nordisk Asks FDA To Halt Production Of Compounded Fat Loss Drugs Due To Their 'Inherent Complexity'
"Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them," said the company in a statement, according to the report.Novo Nordisk (NYSE:NVO) has appealed to the U.S. Food and Drug Administration (FDA) to halt the production of compounded versions of its drugs Wegovy and Ozempic by compounding pharmacies. These cheaper alternatives have been under scrutiny due to potential safety risks and lack of FDA approval.
諾和諾德（紐交所：NVO）已向美國食品藥品監督管理局（FDA）提出上訴，要求停止由混合製劑藥房生產其藥物Wegovy和Ozempic的複方版本。這些更便宜的替代品由於潛在的安全風險和缺乏FDA批准而受到審查。
What Happened: The Danish pharmaceutical giant lodged a request on Tuesday for the FDA to prohibit the production of unapproved versions of its weight loss drug Wegovy and diabetes treatment Ozempic, as reported by CNBC.
發生了什麼：據CNBC報道，這家丹麥製藥巨頭週二提出請求，要求FDA禁止生產其減肥藥Wegovy和糖尿病治療藥Ozempic未經批准的版本。
Novo Nordisk contends that the complexity of these medications makes it unsafe for them to be produced by other manufacturers. The FDA has not made a final decision on whether to ban compounded versions of semaglutide, the active ingredient in both drugs.
諾和諾德認爲，這些藥物的複雜性使它們不適合由其他製造商生產。FDA尚未就是否禁止複方版本的semaglutide做出最終決定，而semaglutide是這兩種藥物的活性成分。
"Semaglutide products fit this description due to their inherent complexity and the potential dangers associated with attempting to compound them," said the company in a statement, according to the report.
該公司在一份聲明中表示：「Semaglutide產品符合這一描述，因爲它們具有固有的複雜性，以及試圖混合它們可能帶來的潛在危險。」
This is the latest in a series of actions by Novo Nordisk to combat the production of potentially harmful semaglutide copies, following 50 lawsuits filed against various clinics, compounding pharmacies, and manufacturers over the past year. The company is working to increase the supply of semaglutide to meet the high U.S. demand.
這是諾和諾德採取的一系列行動中最新的一步，以打擊潛在有害的semaglutide仿製品的生產，在過去一年中針對各種診所、混合製劑藥房和製造商提起了50起訴訟。該公司正在努力增加semaglutide的供應以滿足美國高需求。
Why It Matters: The demand for compounded versions of semaglutide has surged due to intermittent U.S. shortages of the branded drugs, which cost $1,000 per month before insurance and other rebates. Many health plans do not cover semaglutide for weight loss, making compounded versions a more affordable alternative.
爲什麼重要：由於品牌藥物偶爾短缺，價格爲每月1000美元，而且在獲得保險和其他折扣之前，許多健康計劃都不包括減肥藥semaglutide，所以人們對複方semaglutide的需求激增，這使其成爲更經濟的選擇。
In November 2023, Novo Nordisk sued Florida compounding pharmacies over impurities in their products claiming to contain semaglutide. In May this year, Australia banned compounded versions of weight-loss drugs like Novo Nordisk's Ozempic due to safety concerns.
2023年11月，諾和諾德起訴佛羅里達混合製劑藥房，因其產品中檢測到的含有semaglutide的雜質。今年5月，澳大利亞由於安全擔憂禁止了類似諾和諾德Ozempic的減肥藥複方版本。
As the weight-loss drug market expands, companies like Hims & Hers Health, Inc. (NYSE:HIMS) have found a niche by offering affordable alternatives to popular anti-obesity medications. However, concerns over the sustainability of this business model have grown as big pharmaceutical companies ramp up production to meet demand.
隨着減肥藥市場的擴大，Hims & Hers Health, Inc.（紐交所：HIMS）等公司通過提供流行抗肥胖藥的經濟替代品而找到了市場定位。然而，隨着大型製藥公司增加生產以滿足需求，對這種商業模式可持續性的擔憂也在增加。
In October, Eli Lilly And Co. (NYSE:LLY) also increased its legal campaign against compounding companies making and selling copycat versions of its blockbuster drugs for weight loss.
十月份，禮來（紐交所: LLY）也加大了對合成藥公司的法律訴訟，這些公司製造和銷售其減肥明星藥物的仿製品。
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This story was generated using Benzinga Neuro and edited by Shivdeep Dhaliwal
本報道使用Benzinga Neuro生成，並由Shivdeep Dhaliwal
譯文內容由第三人軟體翻譯。
