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The agency highlighted risks including dosing errors, contamination, and the use of unapproved salt forms in compounded versions, some of which resulted in adverse events requiring hospitalizations.[3] This followed previous statements by the FDA concerning unapproved GLP-1 drugs used for weight loss, including concerns with compounded versions of the drug, fraudulent compounded GLP-1 drugs, and versions sold falsely for research purposes or not for human consumption.[4] Import Alert 66-80 now ties enforcement to the Green List by authorizing detention without physical examination of GLP-1 API shipments from non-listed firms
Therefore, early discovery and motions will focus on addressing whether the claims are pre-empted by federal law, and whether plaintiffs must provide specific gastroparesis diagnostic testing evidence in the Ozempic, Wegovy and Mounjaro lawsuits
We don't prescribe based on a 3-question intake form
This has major implications for treatment planning
Its development has focused on Alzheimers disease and other disorders that would benefit from augmented synaptic connectivity
