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Scientific and Regulatory Considerations for the Approval of the First Generic Glucagon

Glucagon for Injection (NDA 020928) is a polypeptide hormone identical to human glucagon approved 20 years ago for severe hypoglycemia in patients with diabetes mellitus. On Dec 28, 2020, the U.S. FDA approved the first generic version of glucagon for injection USP, 1 mg/vial packaged in an emergenc...

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Dades bibliogràfiques
Publicat a:J Endocr Soc
Autors principals: Pang, Eric, Chong, William, Luke, Markham C
Format: Artigo
Idioma:Inglês
Publicat: Oxford University Press 2021
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Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC8089900/
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1210/jendso/bvab048.662
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