The US Food and Drug Administration (FDA) has ordered specialty pharmacies, online companies, and other businesses to stop selling off-brand versions of Eli Lilly’s weight loss medications Zepbound and Mounjaro. The move comes as the shortage of these prescription drugs has been resolved.
Safety concerns have prompted the FDA to issue warnings against unapproved versions of GLP-1 drugs, including tirzepatide-based medicines like semaglutide and tirzepatide itself. Patients are advised to obtain approved medications through a prescription from their doctor at a state-licensed pharmacy.
According to Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, Lilly’s supply is currently meeting or exceeding demand, rendering off-brand versions unnecessary. The FDA has given businesses until 60 to 90 days to cease distribution of off-brand products.
The decision affects Lilly, the manufacturer of Zepbound and Mounjaro, as well as patients seeking affordable weight loss medication. The FDA’s move could lead to higher prices for approved medications due to reduced competition from unapproved versions.
Source: https://eu.usatoday.com/story/news/health/2024/12/24/fda-says-shortage-of-weight-loss-drugs-manufactured-by-eli-lilly-is-over/77202443007