financetom
Business
financetom
/
Business
/
US FDA warns online vendors selling unapproved weight-loss drugs
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
US FDA warns online vendors selling unapproved weight-loss drugs
Dec 17, 2024 2:38 PM

Dec 17 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it has sent

warning letters to four companies for selling unapproved versions of GLP-1 drugs including

semaglutide and tirzepatide, the active ingredients in popular diabetes and weight-loss drugs.

The letters were issued to Xcel Peptides, Swisschems, Summit Research and Prime Peptides

last week after the U.S. health regulator conducted a review of their respective websites in

October.

The websites indicate that their products are labeled as "research use only" or "not for

human consumption or clinical use." However, evidence gathered by the FDA establishes that these

products are actually intended to be used as drugs for humans.

The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded

oral GLP-1 products, including one that claims to be approved by the FDA.

The FDA has observed that the website offers misbranded products that misleadingly suggest

that the drug products are approved or endorsed by the agency in some way.

The companies must inform the agency within 15 business days of receiving the letter,

outlining the specific actions taken to address any violations. Failure to adequately address

the violations may result in legal action including, without limitation, seizure and injunction,

the FDA said.

Semaglutide is an active ingredient in Novo Nordisk's Wegovy and Ozempic, while

Eli Lilly's ( LLY ) diabetes drug sold as Mounjaro and weight-loss drug Zepbound use the

ingredient tirzepatide.

Some of the websites were also offering retatrutide, Eli Lilly's ( LLY ) experimental next

generation weight-loss drug.

The companies have previously sued various medical spas, compounding facilities and clinics

for selling products purporting to contain the active ingredients.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
Update: Artis To Implement Automatic Purchase Plan; Comes After Boosting Holdings In Dream Office REIT To 16.76%
Update: Artis To Implement Automatic Purchase Plan; Comes After Boosting Holdings In Dream Office REIT To 16.76%
Mar 5, 2024
08:40 AM EST, 03/05/2024 (MT Newswires) -- Artis Real Estate Investment Trust (AX-UN.TO) said Tuesday that it is implementing an automatic purchase plan as part of its previously announced normal course issuer bid. The plan allows Artis to purchase units at times when the company is not active in the market due to self-imposed trading blackout periods. This comes after...
Regenxbio Reports Higher Microdystrophin Expression in Phase 1/2 Duchenne Study
Regenxbio Reports Higher Microdystrophin Expression in Phase 1/2 Duchenne Study
Mar 5, 2024
08:39 AM EST, 03/05/2024 (MT Newswires) -- Regenxbio ( RGNX ) reported new data Tuesday about its investigational gene therapy RGX-202 showing significantly increased microdystrophin expression at dose level 2 with early evidence of strength and motor function improvement in a 12-year-old patient with Duchenne muscular dystrophy. The company said the patient's microdystrophin expression was 75.7% at three months, while...
Ballard Power Systems Announcing 15 MW Order For Stationary Power Market; No Financials Given
Ballard Power Systems Announcing 15 MW Order For Stationary Power Market; No Financials Given
Mar 5, 2024
08:38 AM EST, 03/05/2024 (MT Newswires) -- Ballard Power Systems ( BLDP ) announced Tuesday an order for 15 megawatts (MW) of fuel cell systems from a UK-based company specializing in renewable off-grid power generation. According to a statement, Ballard expects to deliver 150 x FCmove-HD+ 100 kW systems beginning in late 2024 and continuing through 2025. No financials were...
Toyota Motors to Acquire Full Ownership of Automotive Battery Maker Primearth EV Energy From Panasonic
Toyota Motors to Acquire Full Ownership of Automotive Battery Maker Primearth EV Energy From Panasonic
Mar 5, 2024
08:43 AM EST, 03/05/2024 (MT Newswires) -- Toyota Motor ( TM ) said Tuesday it has agreed with Panasonic Holdings to acquire full ownership of Primearth EV Energy to support the mass production of automotive batteries. Toyota ( TM ) currently holds nearly 81% of PEVE, with Panasonic holding the remaining. The company said after the acquisition, slated for late...
Copyright 2023-2026 - www.financetom.com All Rights Reserved