NDAINTRAVENOUSEMULSION
Approved
Jul 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Mechanism of Action
Pharmacologic Class:
Lipid Emulsion
Clinical Trials (5)
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Started Oct 2024
100 enrolled
Malnutrition, ChildMalnutritionEssential Fatty Acid Deficiency (EFAD)+1 more
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Started Dec 2019
1 enrolled
Malnutrition, Child
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
Started Dec 2015
204 enrolled
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Can SMOFlipid®, A Composite Parenteral Nutrition Lipid Emulsion, Prevent Progression Of Parenteral Nutrition Associated Liver Disease In Infants?
Started Jan 2009
24 enrolled
Short Bowel SyndromeIntestinal FailureGastrointestinal Motility Disorder+1 more
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Started Oct 2007
75 enrolled
Parenteral Nutrition