Baxter Receives FDA Approval for Clinolipid (Lipid Injectable Emulsion) in Neonatal and Pediatric Use

Baxter, a global leader in nutrition therapy, today announced U.S. FDA approval for an expanded indication of Clinolipid (Lipid Injectable Emulsion) for use in pediatric patients, including preterm and term neonates. Clinolipid is Baxter’s proprietary mixed oil lipid emulsion designed to provide calories and essential fatty acids in parenteral (intravenous) nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. Previously available in the U.S. for adults since 2019, Clinolipid is now approved for all age groups.

“Improving patient outcomes inspires our work every day, and we are proud to continue to address the unique nutritional needs of neonatal and pediatric patients through innovative products and therapies,” said Cecilia Soriano, president of Baxter’s global Infusion Therapies and Technologies division. “Expanding access to Clinolipid for this critical and vulnerable patient population offers clinicians versatility in choosing the product that best meets their patients’ needs when it matters most.”

A Mixed Lipid Emulsion with Unique Characteristics

Parenteral nutrition is crucial in treating and reducing the risk of malnutrition. In the U.S., about 40 percent of patients who receive PN as an intravenous source of nourishment are under the age of 18. Intravenous lipid emulsions (ILEs) are essential for providing calories and essential fatty acids to patients who cannot intake sufficient nutrition orally or enterally. Over recent years, clinical practice has shifted from using 100 percent soybean oil lipid emulsions to mixed lipid emulsions. Baxter’s Clinolipid, which contains 20 percent soybean oil and 80 percent olive oil, has the lowest amount of soybean oil and the highest amount of olive oil of any mixed ILE available in the U.S. today. With more than 150 million doses administered worldwide, Clinolipid has proven to be a safe and effective source of energy and essential fatty acids necessary for growth and development in neonatal and pediatric patients.

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