The decision that will eventually bar compounding pharmacies from making unbranded versions of the injection.
The Food and Drug Administration said the active ingredient in Eli Lilly's weight loss drug Zepbound is no longer in shortage, a decision that will eventually bar compounding pharmacies from making unbranded versions of the injection.
The agency's decision, based on a comprehensive analysis, marks the end of a period where certain pharmacies could make, distribute or dispense unapproved versions of tirzepatide – the active ingredient in Zepbound – without facing repercussions for violations related to the treatment's shortage status.
It's the latest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Eli Lilly's diabetes treatment Mounjaro. Eli Lilly hasthe FDA on Oct. 8 over the agency's decision to remove tirzepatide from its official drug shortages list just days earlier. The group alleges the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists.
The U.S. Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency hasPatients have turned to compounded versions of tirzepatide amid intermittent U.S. shortages of the branded drugs, which carry hefty price tags of $1,000 per month before insurance and other rebates. Many health plans don't cover tirzepatide for weight loss, making compounded versions a more affordable alternative.
Biotechnology Biotech And Pharmaceuticals Pharmaceuticals Health Care Industry LILLY DRN Breaking News Breaking News: Business Social Issues United States Business News
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Zepbound results in more weight loss than Wegovy in trial, Eli Lilly saysBerkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
Read more »
Eli Lilly invests $3B to expand Wisconsin factory to help meet demand for Mounjaro, ZepboundEli Lilly is spending another $3 billion to bulk up manufacturing as the drugmaker seeks to stoke production of some blockbuster drugs and future products.
Read more »
Eli Lilly invests $3B to expand Wisconsin factory to help meet demand for Mounjaro, ZepboundEli Lilly is spending another $3 billion to bulk up manufacturing as the drugmaker seeks to stoke production of some blockbuster drugs and future products.
Read more »
Eli Lilly invests $3B to expand Wisconsin factory to help meet demand for Mounjaro, ZepboundEli Lilly is spending another $3 billion to bulk up manufacturing as the drugmaker seeks to stoke production of some blockbuster drugs and future products.
Read more »
Zepbound Bests Wegovy for Weight Loss in New TrialZepbound, the new GLP-1 weight-loss drug from Eli Lilly & Co., has outperformed its main competitor, Wegovy, in a clinical trial funded by Lilly.
Read more »
Is Ozempic Safe For Weight Loss? Doctors Share Benefits And RisksA new study is out that compares the effectiveness of two popular weight loss drugs, Wegovy and Zepbound. The study, which was conducted by Eli Lilly, the maker of Zepbound, found that weight loss with Zepbound was significantly more than Wegovy. NBC News medical contributor Dr.
Read more »