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More than 50 warning letters to GLP-1 compounders and manufacturers
Read more: More than 50 warning letters to GLP-1 compounders and manufacturersThe FDA issued over 50 warning letters to US and international companies compounding or manufacturing semaglutide and tirzepatide. The cited conduct centered on marketing compounded GLP-1s as “generic versions” of the approved drugs, or making direct comparative claims against them. Sources: FDA warning letter database · Wilson Sonsini analysis
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Court declines to force tirzepatide back onto the shortage list
Read more: Court declines to force tirzepatide back onto the shortage listThe US District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction, which had sought to prevent the FDA from keeping tirzepatide off the drug shortage list. Consequential for the compounding market: shortage status is the legal basis for much large-scale compounding of a drug, so the…
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FDA warning letter to USA Peptide over semaglutide and tirzepatide
Read more: FDA warning letter to USA Peptide over semaglutide and tirzepatideThe FDA issued a warning letter to USApeptide.com for introducing unapproved and misbranded semaglutide and tirzepatide into interstate commerce. The agency cited inadequate directions for use and pointed to evidence that the products were intended for human applications including weight loss and diabetes management — despite research-use-only labeling. An early instance of the argument the…
