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Description
FDA and European Medicines Agency (EMA) have concluded that there is no direct evidence for the association of the use with GLP-1RAs with pancreatitis or pancreatic cancer

Fortunately, no tachyphylaxis was observed

Pharmaceutical stability data indicates expired injectable peptides may retain only 5070% of stated concentration after the expiration date, depending on storage conditions

Biogen will need to address these documentation requirements before the application can be reconsidered
The Journal of Clinical Psychiatry, 65 (7), 959965
