PARIS (dpa-AFX) – The U.S. Food and Drug Administration announced that Sanofi-Aventis U.S. LLC’s Merilog (insulin-aspart-szjj) becomes the first rapid-acting insulin biosimilar product to get its approval for the treatment of diabetes in adults and pediatric patients.
Merilog has been approved as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval is for both a 3 milliliter or mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
As a rapid-acting human insulin, Merilog helps to lower mealtime blood sugar spikes to improve control of blood sugar in people with diabetes.
Like Novolog, Merilog is required to be administered within five to ten minutes prior to the start of a meal. Merilog is administered subcutaneously (under the skin) by injection into the stomach, buttocks, thighs or upper arms. Merilog’s dosing needs to be individualized and adjusted based on the patient’s needs.
Meanwhile,
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