This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.
Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. The FDA still has to make a decision on whether to officially place semaglutide on the lists.
The move was a clear warning to compounders that they can no longer make copycat versions of the drugs — a process that is only permitted when the medications are on an official agency shortage list. Read the rest…
The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.
A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list.
As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S.
judge dismissed its lawsuit accusing a compound pharmacy of selling versions of its Wegovy and Ozempic medicines, which are widely prescribed for weight loss and have become franchise products for the drug company. The drug maker argued the compounders were selling versions of its medicines that were never approved by the U.S.
The deal marks a noteworthy development for Ro, which has been one of the major telehealth platforms providing compounded copies of GLP-1 obesity drugs during shortages of the branded treatments. Continue to STAT+ to read the full story…
At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need.
One of the largest compound pharmacy operations in the U.S. Yet the compounder failed to investigate the causes or take adequate corrective or preventive actions to mitigate the risk of formation. The Food and Drug Administration found several issues that raised the possibility of contamination during an inspection of an Allentown, Pa.,
Novo Nordisk filed lawsuits against two compounding pharmacies for selling adulterated and misbranded compounded drugs claiming to contain semaglutide, the active ingredient in Wegovy and Ozempic (see here and here ). Testing of compounded drugs from these pharmacies revealed unknown impurities up to 33%, the company claims.
In late May, the Food and Drug Administration said it received a “few” adverse event reports concerning compounded versions of the injectable medicines, which both contain the same active ingredient, known as semaglutide.
Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly. Continue to STAT+ to read the full story…
Australia to ban compounded versions of blockbuster drugs Ozempic and Mounjaro, Reuters reports. But the country’s health minister, Mark Butler, says that it’s harder to ensure the safety of compounded drugs, noting that one Australian was hospitalized after taking a compounded GLP-1 product.
… Novo Nordisk disclosed that it is aware of 10 deaths and 100 hospitalizations resulting from people taking compounded copies of its weight loss and diabetes drugs , Reuters writes. We enjoy your insights and perspectives. Given all the U.S. could inject themselves with a product that was not regulated, approved, or inspected.
Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.
Food and Drug Administration seeking to block compounding pharmacies in the U.S. We hope you have a meaningful and manageable day. Best of luck, and do keep in touch. … Novo Nordisk filed another citizen’s petition with the U.S. from making versions of one of its GLP-1 agonist drugs , Pharmaphorum notes.
Also, compounding pharmacies fire back at Novo Nordisk for its assertion that GLP-1 drugs are too difficult to compound. Lots today on GLP-1s: First we see tirzepatide outperforming semaglutide in a head-to-head study in obesity. Also, a Michael Gilman company pivots and more. Read the rest…
I first met Jane (not her real name, of course) on a Friday afternoon in our clinic. She was referred for further evaluation of her chest pain, which, in the context of her family history of early-onset heart attacks and her morbid obesity, understandably concerned her primary care doctor.
Hims & Hers Health plans to sell compounded versions of Novo Nordisk’s popular weight loss drug Wegovy to patients in certain professions for $99 a month , Reuters says. Compounded GLP-1 injections are fulfilled and shipped from Hims & Hers affiliated pharmacies and are regulated by the FDA.
The Food and Drug Administration on Friday said it would reconsider its decision to remove Eli Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, from its shortage list, and, for the time being, would not pursue regulatory action against certain compounding pharmacies making copies of the drugs.
The agency has yet to make a decision about keeping tirzepatide on or off of its shortage list — letting compound pharmacies continue their lucrative operations for now.
A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S. Food and Drug Administration that semaglutide — the key ingredient in its diabetes and obesity drugs — should be added to a list of medicines that are too difficult to compound.
… As the gold rush over weight-loss drugs accelerates, Eli Lilly filed lawsuits against several compounding pharmacies, spas and wellness centers around the U.S. The drug company accused four compound pharmacies of violating state laws because those versions were not approved by the U.S.
Hims & Hers, one of the largest publicly traded telehealth companies in the country, has supercharged its business in the last several months by offering compounded versions of the patented weight loss drugs known as GLP-1s. That has regularly been the case lately with GLP-1 drugs marketed by Novo Nordisk and Eli Lilly.
First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.
By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list. The agency then made a sudden about-face , saying it would reconsider its decision and allow compounders to continue for the meantime.
Over the past two years, patients seeking treatment have been turning to compounding pharmacies, which make cheaper copies of branded treatments and are legally allowed to do so only when the branded treatments are listed on the FDA’s shortage list.
… A trade group representing large compounding pharmacies has sued the U.S. So join us as we hoist the ever-present cup of stimulation — our choice today is coconut rum — and attack the fast-growing to-do list. Have a grand day, everyone, and do stay in touch.
Learn how compounding pharmacies ensure safety and reliability through rigorous standards, sterile preparations, and personalized solutions for unique healthcare needs. The post Are Compounding Pharmacies Safe? Everything You Need to Know appeared first on Compounding Pharmacy of America.
The ADA recommended doctors avoid prescribing unapproved, off-brand versions of drugs like Wegovy, wading into a dispute that has gripped the FDA and compounding pharmacies over the past few months.
The tornado that struck parts of North Carolina on Wednesday not only damaged the immediate area, but could soon make it much harder for countless people across the U.S. and around the world to obtain needed medicines the next time they visit a hospital. Among the damaged buildings was a Pfizer plant in Rocky Mountain, N.C. hospitals.
Novo Nordisk has asked the FDA to stop compounding pharmacies making cheaper versions of its semaglutide-based therapies for obesity and diabetes, saying the drug is too complex to be made safely by these manufacturers.
In the face of ongoing shortages of the obesity and diabetes medications known as GLP-1s, patients have resorted to a wide array of sources for the drugs, including medical spas and telehealth sites that prescribe compounded versions of the drugs.
Food and Drug Administration recently warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk’s weight-loss and diabetes drugs. It urged healthcare providers and compounders to provide the appropriate syringe size and counsel patients on how to measure the dose,” informed the statement.
Both chemicals are psychoactive compounds found in magic mushrooms, which make users hallucinate. It identified the Schedule I drug psilocin in mushroom candies sold under the brand names Diamond Shruumz and Wonderland Legal Psychedelics. A product sold under the brand Urb contained both psilocybin and psilocin. Read the rest…
A traditional Chinese medicine compound used for cardiac benefits might help reduce the incidence of major adverse cardiac and cerebrovascular events and even cardiac death rates, according to a new study published Tuesday in the Journal of the American Medical Association. However, some outside experts expressed skepticism about the result.
Their isolation and vulnerability compounded the challenges of caring for a newborn, and drove many of these mothers into anxiety and depression. Some mothers had to return to work themselves while they were still recovering from childbirth, or else risk losing their jobs in the fields and fruit-packing houses. Read the rest…
By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list. The agency then made a sudden about-face , saying it would reconsider its decision and allow compounders to continue for the meantime.
Hospitals’ reliance on pharmacist-made drugs, a practice called compounding, has risen in step with worsening drug shortages. When the American Society of Health-System Pharmacists surveyed its members this past summer, 59% said they increased purchases from compounders because of drug shortages.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content