On Feb. 14, the agency approved the drug, a biosimilar to Novolog, for glycemic control improvement in adult and pediatric diabetic patients.
The subcutaneous medication is approved in a 3 milliliter, prefilled pen and a 10 milliliter, multiple-dose vial. Like Novolog, Sanofi-Aventis’ drug should be administered five to 10 minutes before a meal. Side effects include hypoglycemia, severe allergic reactions, hypokalemia, injection site reactions, itching, rash, lipodystrophy, weight gain and swelling.
Merilog is the third FDA-approved insulin biosimilar, joining two long-acting biosimilar products approved in 2021.
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