Is Insulin analogs legal in the US?
Yes, FDA approved for controlling blood sugar in diabetes.
Insulin analogs are FDA-approved to improve glycaemic control in diabetes: rapid-acting lispro (Humalog, 1996), aspart and glulisine, and long-acting glargine (2000), detemir and degludec, among others, with biosimilar and interchangeable versions now on the market. Novo Nordisk discontinued Levemir (insulin detemir) in the US at the end of 2024. 31
Yes. Lispro was first in 1996. Glargine followed in 2000. Aspart, glulisine, detemir and degludec came after. Biosimilar versions of glargine, lispro and aspart have also been approved. 31
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Citations
- Novo Nordisk: Levemir (insulin detemir) discontinuation information novocare.com
- Riddle 2003, Diabetes Care: the Treat-to-Target trial, glargine versus NPH added to oral therapy in type 2 diabetes doi.org
- Eli Lilly: Humalog (insulin lispro) prescribing information uspl.lilly.com
Reference information only, not medical advice. Drawn from the Insulin analogs article, fact-checked against the cited sources. No dosing anywhere on this site.