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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. Anonymous

    What will happen if you miss a dose of insulin?

    I have been a diabetic, Type 2 since 1986. It is not easy to watch what you eat,and to exercise when you have bad legs and a sensitive stomach. Also, I am not getting any younger, I am 60 years old. I take insulin 4 times a day, I test 4 times a day. Can anyone give me advice and be able to tell me what happens if I miss a dose of insulin?

  2. kdroberts

    The short answers is that you woo have higher blood sugar levels temporarily, as said. You will also need to take a little more next time to correct the high, that will depend on the insulin and your treatment plan. The long answer is that depending on how your body works you may start to see stones in your urine and if you go too long without inwulin, possibly go into DKA. That would be if your body does not produce any insulin and your blood sugar gets quite high.

  3. monkeymama

    Hello there! I use insulin via a pump. If I just get my basal (continuous insulin) and don't carb in (bolus), my numbers shoot way up on. Essentially, yes, without taking your insulin like you are suppose to, your numbers will go up. How Much? Every person is going to be different because of our metabolism

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