The Food and Drug Administration on Friday approved a lipid injectable emulsion called Clinolipid for parenteral nutrition in adult patients.
The medication is a source of calories and fatty acids for patients who are unable to eat or drink. It is a lipid emulsion that is a mixture of refined olive oil and refined soybean oil.
“The FDA has been very concerned about the short supply of injectable lipid emulsion products,” said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Clinolipid will help in the effort to resolve this shortage so that patients have access to these parenteral nutrition products.”
Clinolipid can be an effective source of energy in adults. The most common side effects in patients treated with Clinolipid during clinical trials included infectious complications, nausea and vomiting, excess fat in the blood, high blood sugar, low levels of protein in the blood and abnormal liver function tests.
Baxter Healthcare Corporation markets Clinolipid.
