The versions composed of Wegovy and Ozempic of Novo Nordisk must stop the production soon. The demands in the thesis products are in the day, but a ruling of the Federal Court in Texas means that aggravation pharmacies cannot continue making their products as the legal process continues.
The order of April 24 by the judge of the United States District Court, Mark Pittman, was sealed. But the decision maintains the determination of the FDA that the shortage of metabolic medications has resolved. The law allows versions composed of a brand medication only whenever a brand product is scarcity.
Traditional compound pharmacies, also known as 503A facilities for the section of the act of food, drugs and cosmetics that cover them, should stop manufacturing medications immediately. These pharmacies are mainly regulated by state pharmacy boards.
Outsourcing facilities, which are found in section 503b of the code, make large amounts of compound products and are under the supervision of the FDA. When the FDA declared the scarcity resolved for the semaglutida, the main pharmaceutical ingredient in Wegovy and Ozempic, the agency gave 503b facilities until May 22 to stop making compound versions. The decision of the Federal Court leaves intact the expiration of this period of grace. After that point, the FDA can take application measures against 503b regulated companies that continue to make compound semaglutid products.
The demand challenged the determination of the FDA was presented by the Association of Outsourcing Facilities, which represses the 503b facilities. The president of the commercial group, Lee Rosebeh, told Reuters that the association presented additional evidence of a scarcity in progress after the lawsuit was filed, but Pittman refused to consider it. Rosebush added that the association believes that the data shows that a shortage remains.
Novo Nordisk said that FDA determination was based on its review of the “stable and growing supply of these important medications approved by the company’s FDA.”
“We are pleased that the court has rejected the attempts of the compounds of undermining the decision based on FDA data that the shortage of Wegovy® and Ozempic® is resolved,” Steve Benz by Novo Nordisk, corporate, legal and American vice president.
For much of the last two years, a strong demand exceeded Novo Nordisk to provide Ozempic and Wogovy, which leads to the shortage of those products. The metabolic medications of Eli Lilly Mounjaro and Zepbound were also scarce. Persistent scarcity left the open for compounds to intensify to meet market demand with their versions of metabolic medications.
Novo Nordisk and Lilly have been making important investments in manufacturing capabilities to address the demand for their products. While part of that capacity has not yet been connected, both pharmaceutical giants have increased their production enough to relieve scarcity. For the tirzepatido, the main pharmaceutical ingredient in Lilly products, the FDA declared that the shortage was resolved last December. The FDA declared the shortage of semaglutid products resolved in February.
Medication manufacturers also introduced lower cost options to compete better against compounds. Last summer, Lilly added the Zepbound Obesity drug to Lillydirect, its direct online platform to the patient. Novo Nordisk responded last month with Novocare, a new online pharmacy that provides Wagovy directly to eligible patients.
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