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Food and Drug Administration approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous use in generalized myasthenia gravis

The warnings, dated December 10, were issued to Prime Peptides, Summit Research Peptides, Swisschems and Xcel Research, all of which were found to be selling unapproved GLP-1 treatments that, despite being labelled as for research purposes, were marketed for human use

The association between paracetamol intake, elevated 5-oxoproline levels and a raised anion gap metabolic acidosis has been highlighted in case reports however the incidence of metabolic acidosis caused by excess 5-oxoproline is unknown

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However, if the FDA ultimately reclassifies them, clinicians would have discretion to write prescriptions outside of those narrow indications