Baxter Secures FDA Approval of Clinolipid (Lipid Injectable Emulsion) Neonatal and Pediatric Indication

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

“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 plays an important role in helping treat and reduce the risk of malnutrition. In the U.S., it’s estimated that about 40 percent of patients who receive PN as an intravenous source of nourishment are under the age of 18.^1,2 Intravenous lipid emulsions (ILEs) are used to provide calories and essential fatty acids for patients who cannot intake a sufficient source of nutrition orally or enterally. Over the last several years, clinical practice has shifted away from using 100 percent soybean oil lipid emulsions – which was the standard of care for decades – to mixed lipid emulsions. Baxter’s Clinolipid contains the lowest amount of soybean oil (20 percent) and highest amount of olive oil (80 percent) of any mixed ILE available in the U.S. today.^3,4 With more than 150 million doses worldwide,⁵ Clinolipid has been shown to be a safe and effective source of energy and essential fatty acids needed for growth and development in neonatal and pediatric patients.³ Specifically, Clinolipid:

• Is rich in omega-9 oleic acid, the most prevalent fatty acid in human breast milk;⁶
• Minimizes the decline in post-natal arachidonic acid levels;⁷
• Is supported by extensive PN admixture stability.^8,9

Clinolipid is available to order in the U.S. today. Click here to learn more about Baxter’s clinical nutrition portfolio.