The U.S. Food and Drug Administration (FDA) has confirmed that the shortage of Eli Lilly’s weight-loss drugs, Zepbound and Mounjaro, has been resolved. The FDA is now ordering specialty pharmacies and online retailers to halt the sale of off-brand versions of these drugs.
The FDA issued warnings against these unapproved alternatives, highlighting potential safety risks. Some patients and healthcare providers may seek out unapproved versions of GLP-1 drugs, including semaglutide and tirzepatide, for weight loss,” the agency said last week. “This can be risky for patients, as these versions have not undergone FDA review for safety, effectiveness, and quality before reaching the market.”
The FDA advised patients to obtain these medications only through a prescription from their doctor and to fill the prescription at a state-licensed pharmacy.
Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, confirmed that the demand for both Zepbound and Mounjaro is being met, making off-brand options unnecessary. In a statement last week, she explained, “The information and data provided by Lilly show that the company’s supply is now meeting or exceeding demand, with substantial reserves and increased production planned for the coming months.”
What Does the FDA’s Decision Mean?
Zepbound and Mounjaro belong to the GLP-1 class of drugs, which also includes Novo Nordisk’s Wegovy and Ozempic. These medications have proven effective in helping people lose weight, leading to a surge in demand.
As demand grew, telehealth companies and pharmacies like Hims and Ro began offering off-brand versions of Zepbound and Mounjaro at lower prices. The FDA’s move to stop the sale of these alternatives gives businesses 60 to 90 days, depending on size, to comply.
This decision is seen as a victory for Lilly, the manufacturer of Zepbound and Mounjaro. According to the Associated Press, the move could impact both the prices of these drugs and the ways they are accessed in the future.
What Are Zepbound and Mounjaro?
Both Zepbound and Mounjaro have been FDA-approved, with Zepbound used for obesity treatment and Mounjaro for diabetes management. While they serve different medical purposes, both drugs contain the same active ingredient—tirzepatide.
