DEERFIELD, Ill. - Baxter International Inc. (NYSE:BAX), a global medical products company, has received U.S. Food and Drug Administration (FDA) approval to expand the use of its Clinolipid (Lipid Injectable Emulsion) to pediatric patients, including preterm and term neonates. This approval, announced today, extends the use of Clinolipid, previously available for adults since 2019, to patients of all ages who require intravenous nutrition.
Clinolipid is designed to deliver calories and essential fatty acids intravenously to patients who are unable to consume food orally or enterally. The product is a mixed oil lipid emulsion, containing 20 percent soybean oil and 80 percent olive oil, and is noted for having the highest olive oil and lowest soybean oil content among mixed intravenous lipid emulsions in the U.S. market.
Cecilia Soriano, president of Baxter’s global Infusion Therapies and Technologies division, emphasized the company's dedication to addressing the nutritional needs of neonatal and pediatric patients, stating that the expanded access to Clinolipid allows healthcare providers more options to meet the critical requirements of this vulnerable patient group.
Parenteral nutrition is a critical component in managing malnutrition in patients who cannot meet their nutritional needs through traditional means. Approximately 40 percent of patients receiving parenteral nutrition in the U.S. are under 18 years old. Clinolipid's formulation is said to be effective in providing the energy and essential fatty acids necessary for growth and development in neonatal and pediatric patients.
The product's safety and efficacy have been supported by its use in over 150 million doses worldwide. Clinolipid is also rich in omega-9 oleic acid, a major component of human breast milk, and has demonstrated stable admixture properties for parenteral nutrition.
Baxter's clinical nutrition portfolio includes a range of products and services, such as metabolic monitors, automated nutrition compounders, and parenteral nutrition solutions, which are used in various healthcare settings.
The expanded indication for Clinolipid is based on the product's ability to provide essential nutrition intravenously when other forms of nutrition are not feasible. However, its use is contraindicated in patients with known hypersensitivity to egg, soybean, peanut, or any of the active or inactive ingredients, and in those with severe lipid metabolism disorders.
The information in this article is based on a press release statement from Baxter International Inc.
InvestingPro Insights
Baxter International Inc. (NYSE:BAX) has recently made headlines with the FDA approval of Clinolipid for pediatric use. This development may bolster the company's position in the healthcare market, especially given its role as a prominent player in the Healthcare Equipment & Supplies industry. According to InvestingPro Tips, Baxter has a strong track record of shareholder returns, having raised its dividend for 7 consecutive years and maintained dividend payments for 54 consecutive years. This consistency is a testament to the company's financial stability and commitment to returning value to its shareholders.
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Lastly, it's worth noting that while analysts have revised their earnings expectations downwards for the upcoming period, the overall sentiment remains positive, with predictions of profitability this year. With 9 additional tips listed on InvestingPro, investors have access to a wealth of information to make informed decisions about their investments in Baxter International Inc.
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