BETHESDA, MD 04 Oct 2013—FDA on Thursday approved the marketing of a 20% lipid injectable emulsion, Clinolipid, for use in meeting the nutritional needs of adults when oral or other enteral nutrition is not possible or sufficient.
Agency officials, in a press release dated Thursday but not posted until today, said the marketing application for Clinolipid underwent "priority review" to help alleviate the ongoing shortage of injectable lipid emulsion products.
The new i.v. nutrition product contains a mixture of refined olive oil and refined soybean oil, FDA said.
As with other i.v. lipid emulsions, the agency said, Clinolipid should be used with caution in patients with liver insufficiency or a preexisting liver disease. And patients with hyperlipidemia or a known hypersensitivity to egg or soybean proteins should not receive the product at all.
The most common adverse events in patients who received the lipid injectable emulsion during clinical studies were infectious complications, nausea, vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia, and abnormal liver-function-test results, FDA reported.
Baxter Healthcare Corporation will market Clinolipid.