FDA approves Omegaven ( fish oil triglycerides )

Omegaven (fish oil triglycerides) is a sterile, nonpyrogenic, white, homogenous emulsion for intravenous infusion as a supply of calories in patients with PNAC. Each mL of Omegaven contains 0.1 g of fish oil, 0.012 g egg phospholipids, 0.025 g glycerin, 0.15 to 0.3 mg dl-alpha-tocopherol, 0.3 mg sodium oleate, water for injection, and sodium hydroxide for pH adjustment (pH 6 to 9). The phosphate content is 0.015 mmol/mL.

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

OMEGAVEN is a drug that provides calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

Cholestasis is a condition in which bile is not released from the liver. It may occur when patients are receiving nutrition intravenously (parenteral nutrition).

How is this drug used?

OMEGAVEN is injected into a vein (intravenous) by a healthcare provider and is administered daily over 8 to 24 hours.

What are the benefits of this drug?

Patients treated with OMEGAVEN achieved age-appropriate weight.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

The trials that looked at the benefit of OMEGAVEN were too small to determine if there were any differences in sex, race, and age subgroups.