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Fda Says 'yes' To Short-acting Insulin Admelog

The FDA granted full approval for the first "follow-on" version of short-acting insulin lispro, to be sold as Admelog and indicated for improving glycemic control, the agency announced Monday. The approval covers use in adults with type 2 diabetes, as well as in adults and children at least 3 years old with type 1 diabetes. Typically administered prior to meals, the insulin can be given via injection, through an insulin pump, or by intravenous infusion. Admelog, developed by Sanofi, is a follow-on to Eli Lilly's insulin lispro sold as Humalog and was therefore reviewed under the abbreviated 505(b)(2) pathway, which is separate from the FDA's so-called biosimilar pathway although functionally there is little to distinguish them. Sanofi's insulin lispro had been tentatively approved in September with final approval withheld while patent issues were resolved. Admelog's approval was also based on two phase III clinical trials involving around 1,000 patients. During the clinical trials, the most commonly reported adverse events included hypoglycemia, itching, and rash. Continue reading >>

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Popular Questions

  1. umar54

    How long can insulin be kept out of fridge and how much be kept in temp??

    Please Suggestion

  2. HOBIEONE

    Hello Umar. I have been to some very hot places on my Motorbike (no fridge etc). & camping so no power & only had Frio bags to keep stable temp. People on pumps have insulin next to them upto 3 days ? Shorter the time insulin is out of the fridge the better.

  3. umar54

    If the temp 40 Celsius

    What gonna do?

  4. -> Continue reading
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