Less expensive Ozempic, Wegovy copies restricted after federal court ruling
Less expensive Ozempic, Wegovy copies restricted after federal court ruling
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Ozempic warning: Experts warn of side effects from weight loss drug
Experts are warning of the possible side effects of popular diabetes medications such as Ozempic and Mounjaro when used for weight loss.
The pharmaceutical company that makes the weight-loss drug Wegovy and the diabetes medication Ozempic secured a court victory that limits compounding pharmacies from selling versions of those popular drugs.
A federal judge April 24 rejected a bid by compounding pharmacies to continue selling less expensive copies of semaglutide, Novo Nordisk's blockbuster drug sold under the brands Wegovy and Ozempic.
The court ruling closes a legal window that allowed compounding pharmacies to make and sell large quantities of the lucrative weight-loss drugs. Many consumers turned to these less-expensive compounded versions of the weight-loss and diabetes drugs because they said they could not afford the brand medications.
The Food and Drug Administration allows compounding pharmacies to sell copies of drugs when the medications are in short supply. In February, the FDA declared the semaglutide shortage over and set deadlines for enforcement action against compounding pharmacies and facilities that essentially copied Novo Nordisk's drug.
The FDA said pharmacies or physicians could face enforcement action if they continued to make or dispense compounded semaglutide products beyond April 22. The FDA set a May 22 deadline for facilities that compound, distribute or dispense semaglutide.
The industry trade group Outsourcing Facilities Association sued the FDA in U.S. District Court in Texas and sought a preliminary injunction to delay enforcement while the court case proceeded. But U.S. District Judge Mark Pittman on Thursday denied compounders' bid for a preliminary injunction.
'We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy and Ozempic is resolved,' Steve Benz, Novo Nordisk's corporate vice president, legal and general counsel, said in a statement.
Outsourcing Facilities Association Chairman Lee H. Rosebush said the organization is "deeply disappointed" the court failed to consider "clear and convincing evidence" that existing supply of semaglutide doesn't meet consumers' demand.
"We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA," Rosebush said. "We will not stop in our efforts to ensure that patients can get access to this vital medication.'
In December, the FDA declared that Eli Lilly's weight loss and diabetes medication tirzepatide, sold under the brand names Mounjaro and Zepbound, was no longer in short supply. The Outsourcing Facilities Association unsuccessfully sought a preliminary injunction to continue marketing compounded tirzepatide.
March 5, a federal judge rejected the request for a preliminary injunction. That means pharmacies and facilities that sell batches of the medication could face FDA enforcement.
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