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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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Bibliografski detalji
Izdano u:J Endocr Soc
Glavni autori: Pang, Eric, Chong, William, Luke, Markham C
Format: Artigo
Jezik:Inglês
Izdano: Oxford University Press 2021
Teme:
Online pristup: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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