insulin human

FDA Drug Profile — MYXREDLIN

insulin human is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand name including MYXREDLIN. Available dosage forms: powder, injection, solution.

Drug Details

Generic Name
insulin human
Brand Names
MYXREDLIN
Application Number
BLA208157
Sponsor
Virtu Pharmako (Zhejiang) Co., Ltd.
NDC Codes
7
Dosage Forms
POWDER, INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
INSULIN HUMAN

Indications and Usage

1 INDICATIONS AND USAGE AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis (DKA) ( 1 ) Not recommended in patients who smoke or who have recently stopped smoking ( 1 ) Limitations of Use: AFREZZA is not recommended for the treatment of diabetic ketoacidosis (DKA) [see Warnings and Precautions ( 5.6 )] . The safety and effectiveness of AFREZZA in patients who smoke have not been established. The use of AFREZZA is not recommended in patients who smoke or who have recently stopped smoking [see Warnings and Precautions ( 5.5 )].