The US Food and Drug Administration (US FDA) has granted approval to B. Braun Medical's Nutrilipid 20 per cent (I.V. fat emulsion) for parenteral nutrition therapy in adult & paediatric patients. Nutrilipid 20 per cent is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated.
The approval of Nutrilipid 20 per cent will help alleviate the short supply of lipid emulsion products the US has seen over the past two years. It will be available in flexible containers that are not made with DEHP, PVC or natural rubber latex. Launch plans are expected soon.
“We are very pleased that the FDA has granted approval for Nutrilipid 20 per cent,” said Rick Williamson, vice president of pharmaceutical marketing at B.Braun. “Through our state-of-the-art production facility, we are committed to providing quality clinical nutrition products so that patients have access to parenteral nutrition they often critically need. B.Braun continues to expand upon its customised approach to clinical nutrition and compounding to meet the needs of patients along the entire clinical pathway," added Williamson.
B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety.