insulin aspart

FDA Drug Profile — Insulin Aspart Protamine and Insulin Aspart Mix 70/30, NOVOLOG, NovoLog Mix 70/30, Fiasp, NOVOLOG MIX 70/30

Drug Details

Generic Name
insulin aspart
Brand Names
Insulin Aspart Protamine and Insulin Aspart Mix 70/30, NOVOLOG, NovoLog Mix 70/30, Fiasp, NOVOLOG MIX 70/30, Insulin Aspart, .Insulin Aspart Protamine and Insulin Aspart
Application Number
BLA021172
Sponsor
Novo Nordisk Pharma, Inc.
NDC Codes
27
Dosage Forms
INJECTION, SUSPENSION, INJECTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
INSULIN ASPART

Indications and Usage

1 INDICATIONS AND USAGE Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is not recommended for the treatment of diabetic ketoacidosis. • The proportions of rapid-acting and long-acting insulins in Insulin Aspart Protamine and Insulin Aspart Mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments. Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis. • The proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments (1) .