
FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog
Feb 14, 2025 · Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). Other common side effects may include injection site reactions, itching, rash, lipodystrophy (skin thickening or pitting at the injection site), weight gain and swelling of hands and feet.
FDA Approves First Rapid-Acting Insulin Biosimilar Product for ...
Feb 14, 2025 · Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Merilog helps to lower mealtime blood...
FDA Approves Merilog, a Rapid-Acting Insulin Biosimilar Product
2 days ago · Merilog 100units/mL is supplied as both a 10mL multi-dose vial as well as a 3mL single-patient-use prefilled pen; the prefilled pen dials in 1-unit increments. The rapid-acting insulin should be administered subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks, or upper arm. ...
FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for ...
3 days ago · Merilog is a rapid-acting human insulin analog and the first rapid-acting insulin biosimilar product approved by the FDA. Administering Merilog subcutaneously five to 10 minutes before mealtime helps improve glycemic control in patients with diabetes. Both a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial are included in ...
FDA Approves Sanofi's Merilog As First Rapid-Acting Insulin
4 days ago · Merilog is available in a 3 mL prefilled pen and a 10 mL vial, joining two long-acting insulin biosimilars approved by the FDA in 2021. Merilog, a rapid-acting human insulin analog, is the first ...
FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for …
Feb 14, 2025 · The US Food and Drug Administration (FDA) has approved the first rapid-acting insulin biosimilar, Merilog (insulin aspart-szjj), for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus, according to an FDA news release. 1. Merilog is a biosimilar to Novolog (insulin aspart) and will be available in a 3-mL prefilled pen and a 10-mL multiple-dose vial.
FDA Approves Merilog: What It Means for the Diabetes Biosimilar …
3 days ago · The U.S. Food and Drug Administration (FDA) has approved Merilog (insulin aspart-szjj), a biosimilar to NovoLog (insulin aspart), marking a significant expansion in diabetes treatment options. Developed by Meitheal Pharmaceuticals and Tonghua Dongbao Pharmaceutical, Merilog aims to enhance insulin accessibility and affordability for millions of Americans living with diabetes.
FDA Approves Merilog Rapid-Acting Insulin Biosimilar For Diabetes
5 days ago · Merilog's dosing needs to be individualized and adjusted based on the patient's needs. Meanwhile, Merilog may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions and hypokalemia (low potassium in blood). It may also cause other common side effects such as injection site reactions, itching, rash ...
Merilog (insulin aspart-szjj) FDA Approval History - Drugs.com
5 days ago · Merilog is administered by subcutaneous injection. FDA approval of Merilog was based on data that demonstrated that Merilog is biosimilar to NovoLog. Warnings and precautions associated with Merilog include hyperglycemia or hypoglycemia with changes in insulin regimen, hypoglycemia which may be life-threatening, hypersensitivity reactions, and ...
FDA approves Merilog, first NovoLog biosimilar for diabetes
2 days ago · Merilog's approval represents a major step toward expanding the biosimilar insulin market, promoting competition and increasing access to vital diabetes treatments. As the FDA remains focused on advancing biosimilar development, stakeholders must adapt to shifting dynamics in pricing, market adoption and long-term cost savings.
- Some results have been removed