Boxes of ozempic and wegovy made by novo nordisk are seen at a pharmacy.
Hollie Adams | Reuters
The long-running us shortage of Novo Nordisk‘S Blockbuster Weight Loss Injection Wegovy and Diabetes Treatment OzEMPIC is Resolved after more than two years, the food and drug administration said on Friday.
The FDA’s decision will think the ability of compounding pharmacies to make far cheaper, unbranded versions of the injections over the next few months. Many patients related on unapproved versions of Wegovy and Ozepic Since Compounding Pharmacies are allowed to make versions of branded medicines in short support.
Novo Nordisk’s stock rose about 5% on Friday. Meanwhile, Shares of Hims & HersAa Telehealth Company Offering Compounded Wegovy and OzEmpic, Fell Roughly 20%.
The active ingredient in both of novo Nordisk’s injectable drugs, semaglutide, has been in shortage in the US since 2022 after demand. That has forced novo nordisk and its rival Eli lilly To invest heavily to expand their manufacturing footprints for their respective weight loss and diabetes drugs – and it may be paying off.
The FDA determined that novo Nordisk’s supply and manufacturing capacity for semaglutide injections can now meet the current and projected demand in the us still, the agency noted tes and present See “Intermittent and Limited Localized Supply Disrupties” As Products Move Through the Supply Chain to Pharmacies.
“We are please the fda have declared that supply of the only real, FDA -Proved Semaglutide Medicines is resolved,” Dave Moore, NOVO NORDISK’s Executive Vice Presidents and Global Jills Development, said in a statement.
He added that “no one should have to compromise their health due to misinformation and record for fake or Illegitimate knockoff drugs that Pose Significant Safety Risks to Patients.”
The FDA’s Announcement Comes Just Months after the Agency declared The shortage of tirzepatide – the active ingredient in Eli Lilly’s Weight Loss Injection Zepbound and diabetes counterpart mounjaro – Over.
The FDA’s Decision on Friday Decision Could Better Position Novo Nordisk to Compete with Eli Lilly in the Booming Weight Loss Loss Drug Market, Why Somena Analysts Say COLD BLED BILLD BILLD BILLD BILLD POLLENALELY After 2030.
Threat to compounded medicines
The agency’s decision, based on a comprehensive analysis, essentially marks the end of a period where compounding pharmacies could make make makes, distribute or dispenses unapproved versions Without Facing Reepercussions for Violations Related to the Treatment’s Shortage Status.
Compounding Pharmacies must stop making compounded versions of semaglutide in the next 60 to 90 days, depending on the type of facility, the agency said. That transition period will likely give vessels to switch to the branded versions of the medicines.
But, in compliance with FDA rules, compounders can still make alternative versions of the drugs if they modify doses, add other ingredients or changes of giving the treatment the treatment to meet a special Needs.
Some Patients relay on Compounded Versions While ozempic is covered by most health plans, weight loss drugs such as wegovy are not currently covered by medicine and other insurance.