FDA Approves Kabiven and Perikabiven

Fresenius Kabi Receives FDA Approval for Kabiven and Perikabiven

LAKE ZURICH, Ill. August 26, 2014 - Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven and Perikabiven, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States. Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition.

Kabiven and Perikabiven are intravenously infused solutions of lipids, dextrose, amino acids and electrolytes in three-chamber parenteral nutrition bags that efficiently deliver these nutrients in volumes and concentrations that meet the nutritional needs of most patients.

The unique three-chamber bag simplifies the delivery of parenteral nutrition by providing a premixed solution that is shelf-stable until activated for patient use.

Outside the United States, Kabiven is sold in more than 85 countries and has been used to treat approximately 9 million patients since its initial marketing authorization in 1999.

“Fresenius Kabi is a leader in providing innovative parenteral nutrition products for health care providers and their patients around the world,” said John Ducker, president and CEO of Fresenius Kabi USA. “We are pleased to bring new alternatives like Kabiven and Perikabiven to U.S. patients. This is especially important as many of the macro- and micro-nutrients in Kabiven and Perikabiven have been in short supply in the United States.”

“The clinical nutrition and pharmacy communities are paying increased attention to improving the safety of parenteral nutrition infusion. Premixed parenteral nutrition solutions such as Kabiven and Perikabiven can be an integral part in standardizing this therapy and can help support PN safety,” said Darlene Kelly, M.D., Ph.D., Advisor for Science and Medicine at the Oley Foundation for Home Parenteral and Enteral Nutrition. “Furthermore, for people who require long-term parenteral nutrition at home, Kabiven and Perikabiven are particularly beneficial because they provide needed nutrition, including lipids, and don’t require refrigeration, making travel more convenient.” Parenteral nutrition is the intravenous administration of nutrition, which includes protein, carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements for patients who cannot digest, or absorb sufficient nutrition via the gastrointestinal tract.

Parenteral nutrition is the intravenous administration of nutrition, which includes protein, carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements for patients who cannot digest, or absorb sufficient nutrition via the gastrointestinal tract.

About Kabiven and Perikabiven

Kabiven and Perikabiven three-chamber bags contain amino acids with electrolytes, dextrose and lipids (Intralipid® 20%). The design of the three-chamber bag keeps the macronutrients separate and shelf-stable until the bag is activated and the contents mixed together for patient use. The formula is intended to meet the daily nutritional requirements of broad patient populations.

Kabiven and Perikabiven three chamber bags must be mixed prior to infusion. For admixing instructions see DIRECTIONS FOR ACTIVATING THE BAG in the prescribing information.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.

Source: Fresenius Kabi USA

Posted: August 2014

Kabiven (amino acids, electrolytes, dextrose and lipid) FDA Approval History

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