The FDA has announced that the supply issues related to Eli Lilly’s weight loss medications, Zepbound and Mounjaro, have been addressed, and that specialty pharmacies and online retailers must cease the sale of off-brand versions of these drugs.

Concerns regarding safety have led the FDA to issue warnings against these unapproved alternatives.

“FDA is aware that some patients and healthcare providers may seek out unapproved GLP-1 drugs, such as semaglutide and tirzepatide, for weight loss,” the FDA stated last week. “Using these alternatives can be dangerous, as they bypass the FDA’s scrutiny for safety, effectiveness, and quality before being sold.”

The agency has advised patients to get prescriptions from their doctors and fill them at state-licensed pharmacies.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, noted in a recent letter that the supply for Zepbound and Mounjaro is currently sufficient, making these off-brand products unnecessary.

“We conclude that the information and data provided by Lilly show that their inventory is currently meeting or exceeding the demand for these products, and they have substantial reserves along with additional production scheduled for the coming months that will fulfill any increased demand,” she explained.

What Are the Implications of the FDA’s Decision?

The GLP-1 medications, including Zepbound and Mounjaro, are part of a broader class of weight-loss treatments like Wegovy and Ozempic produced by Novo Nordisk, all of which have demonstrated effectiveness in promoting weight loss.

As interest in these medications surged, telehealth and compounding pharmacies like Hims and Ro started marketing their own off-brand and more affordable alternatives to Zepbound and Mounjaro.

According to the FDA’s announcement, businesses have between 60 and 90 days to halt the distribution of their off-brand products, depending on their size.

The FDA’s action is seen as a positive development for Eli Lilly, the manufacturer of these drugs. According to the Associated Press, this decision may impact the pricing and availability of Zepbound and Mounjaro.

Overview of Zepbound and Mounjaro

Both Zepbound and Mounjaro have been authorized by the FDA, with Zepbound designated for obesity treatment and Mounjaro for diabetes management. Despite their different indications, both share the same active ingredient, which is tirzepatide.