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|Newsletters: FDA Approves Clinolipid|
FDA Approves Clinolipid (10/2013)
In early October, the U.S. Food and Drug Administration (FDA) approved the IV fat emulsion Clinolipid for parenteral nutrition (PN) in adult patients. Clinolipid had been granted a priority review in an effort to help relieve lipid shortages.
“Approving submissions from manufacturers who can start new production or increase existing production of a product in short supply is one of the many effective mitigation tools that the FDA employs to address a shortage problem,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Clinolipid (marketed by Baxter Healthcare, Illinois) contains a mixture of refined olive oil and refined soybean oil. The ratio of omega-3 fatty acid to omega-6 fatty acid in Clinolipid has not been shown to improve clinical outcomes compared to other IV fat emulsion products. It has been approved for adults. It is not indicated for use in preterm infants, nor is it indicated for use in other pediatric patients. It is not known whether the amount of essential fatty acids found in Clinolipid is enough to meet the nutritional needs of children.
LifelineLetter, November/December 2013
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