I saw Ozempic and Wegovy boxes made by Novo Nordisk in the pharmacy.
Hollie Adams | Reuters
The long-standing shortage of the United States Novo NordiskThe massive weight loss injections Wegovy and diabetes treatment Ozempic are solve More than two years later, the U.S. Food and Drug Administration said Friday.
The FDA’s decision will threaten the ability of compound pharmacies to make injections cheaper, unbranded versions in the next few months. Many patients rely on unauthorized Wegovy and Ozempic versions because they allow compound pharmacies to produce branded drugs that are temporarily available.
Novo Nordisk shares rose about 5% on Friday. At the same time, stocks He and hersAA telemedicine companies offer more sophisticated Wegovy and Ozempic, down about 20%.
Demand has soared since 2022, and the active ingredients of Novo Nodisk’s two injectable drugs, Semaglutide, have been lacking. This forces Novo Nordisk and its competitors Yililai Invest heavily to expand their respective weight loss and diabetes medication manufacturing footprints – it may pay off.
The FDA determines the supply and manufacturing capacity of Semaglutide injections for Novo Nordisk injections can now meet current and projected demand in the U.S., the agency notes that patients and prescribers may still see “intermittent and limited local supply disruptions as products pass through supply. ”The chain goes to the pharmacy.
“We are pleased that the FDA has announced that it has resolved the supply of the only, FDA-approved Semaglutide drug,” Dave Moore, executive vice president of US operations and global business development, Novo Nordisk, said in a statement.
“No one has to compromise on health due to false information and involves counterfeit or illegal generic drugs, which poses a significant safety risk to patients,” he added.
The FDA announcement comes months after the agency Announce Tirzepatide’s shortage – Eli Lilly’s weight loss injections with the active ingredients of Zepbound and diabetes counterparts.
The FDA’s decision in Friday’s decision could better position Novo Nordisk to compete with Eli Lilly in the booming weight loss pill market, with some analysts saying the company could be worth more than $150 billion a year after 2030.
Threat to compound drugs
The agency’s decision is based on a comprehensive analysis, essentially marking the period when compound pharmacies can produce, distribute or distribute unapproved versions of Semaglutide without facing the impact of violations associated with treatment shortage status.
The agency said that depending on the type of facility, the compound pharmacy must stop making the compound version of the Semaglutide within the next 60 to 90 days. This transition period may give patients time to switch to a branded version of the drug.
However, according to FDA rules, the compounder can still make alternative versions of the medication if the dosage is modified, the addition of other ingredients or the method of administration to meet the needs of a particular patient.
Some patients rely on the composite version because they don’t have drug insurance coverage for Novo Nordisk and can’t afford the high-priced label of about $1,000 a month. Although most health plans cover Ozempic, weight loss pills (such as Wegovy) are not currently covered by Medicare and other insurances.
