The Oskempic and Wegovy boxes made by Novo Nordisk can be seen at the pharmacy.
Hollie Adams | Reuters
Long -lasting American drawback Novo NordiskInjection of the weight loss of blockbuster Wegovy and the treatment of a scorer of the scoreboard is resolved After more than two years, the Food and Medication Administration announced on Friday.
The FDA Decision will threaten the ability to compile a pharmacy to become far cheaper in the next few months, with an unpubreased version of injections. Many patients relied on the overwhelming versions of Wegovy and Oskempic because compositioning of pharmacy is allowed to be in the absence of the right version of the branding medication.
Novo Nordiska shares rose about 5%on Friday. Meanwhile, shares HIMS & HERSAA Telehealth Company offering complex Wegovy and Oskempic, it fell approximately 20%.
The active ingredient in both drugs for injection Novo Nordiska, semaglutide, has been missing in the US since 2022. After demanding suddenly jumped. This forced Novo Nordisk and his rival Eli Lilly To invest a large extent to expand their production traces for their weight loss and diabetes medicines – and this can be paid.
The FDA has found that the new Nordisk supply and production capacity for semaglutide injections can now satisfy the current and projected demand in the United States, the agency noted that patients and rules can still see “occasional and limited localized supply disorders” through the supply of a chain to the pharmacy.
“We are pleased that the FDA has stated that the supply of the only real remedies that have been approved by the FDA,” Dava Moore said in a statement by the US business and global development of American business and global business development.
He added that “no one should compromise your health for misinformation and reach for false or illegitimate drugs dealing with Knockoff that represent significant security risks for patients.”
The FDA announcement only comes a few months after the agency declared Tirzepatide deficiency – an active ingredient in Eli Lilly’s injection to injection weight and Mounjaro -Munjaro – Mounjaro.
FDA’s decision could better position Novi Nordisk to compete with Eli Lilly in the leaning market for weight loss, which some analysts say that after 2030 it could be worth more than $ 150 billion.
Threat of complex medication
The decision of the agency, based on a comprehensive analysis, basically indicates the end of the period in which the pharmacy for compiling can be made, distributed or distributed the disapproval versions of the semaglutides without confronting the consequences due to violation of the status of the lack of treatment.
The composers they assemble must stop making complex versions of semaglutides in the next 60 to 90 days, depending on the type of object, the agency said. This transition period is likely to give patients time to move on to the branded versions of the medication.
However, in accordance with the FDA rules, the compounds can continue to make alternative versions of the drug if they change doses, add other ingredients or change the method of giving treatment to meet the patient’s certain needs.
Some patients rely on complex versions because they do not have drug insurance coverage for Novi Nordic and cannot afford their huge prices of approximately $ 1,000 a month. Although Orempic is covered by mostly health plans, weight loss drugs like Wegovy are currently not covered by Medicare and other insurance.
