The Food and Drug Administration said on Friday that there is no longer a shortage of drugs like Wegovy and Ozempic.
The semaglutide known as Ozempic is intended to be used for people with diabetes. Drugmaker Novo Nordisk later got approval to market Wegovy, a semaglutide that has a different dosage, for weight loss.
The drugs have been in short supply since 2022, soon after the FDA approved Wegovy for weight loss purposes.
Novo Nordisk said it made a $6.5 billion investment to increase production in the U.S.
RELATED STORY | Weight-loss pill from Wegovy makers cut body weight by up to 13% in early trial
"We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand. No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients," said Dave Moore, president of Novo Nordisk Inc. "Patient safety remains our top priority and, in line with our purpose to improve lives and health, we continue to partner, educate, and advocate for expanded, affordable access to our medicines for those who need and rely on them."
When the FDA declared a shortage in 2022, pharmacies were allowed to make compounded versions of the drug to meet demand. These drugs use the same active ingredients, but Novo Nordisk claimed this process put patients at risk. However, this also allowed pharmacies to offer these drugs at lower costs.
The list cost of Wegovy is $1,349, and one dose is generally taken every four weeks.
“Non-FDA approved compounded drugs claiming to contain semaglutide with high levels of known impurities and unknown impurities pose significant risks to patients and may lead to serious and life-threatening reactions,” said Novo Nordisk executive vice president of North America operations Doug Langa.
RELATED STORY | So, you've lost weight using Wegovy. Does that mean you can stop taking it?
The company had brought numerous lawsuits against the FDA and companies selling compounded versions of the drug.
The FDA said companies have until May 22 to stop selling compounded versions of the drug and stated that it could take legal action against companies that have sold unsafe copies of the drug.
Medications like Wegovy are known as GLP-1 agonists, and many of these drugs were initially prescribed to manage Type 2 diabetes but have since gained popularity for helping patients manage weight.
According to the Cleveland Clinic, these medications help manage blood sugar levels by triggering insulin release from the pancreas. The drugs also help slow digestion, which causes less glucose to enter the bloodstream. Additionally, the medicine also affects satiety, allowing patients to feel full after eating, according to the Cleveland Clinic.
