Leucovorin Calcium is the newest addition to the company’s large oncology portfolio.

Omegaven® is an intravenous lipid emulsion that provides calories and fatty acids. In the U.S. it is indicated for pediatric patients with parenteral nutrition-associated cholestasis, or PNAC. With Omegaven® Fresenius Kabi provides the first and only FDA-approved fish oil lipid emulsion for this condition.

In the lawsuit by Akorn, Inc. against Fresenius for the consummation of the April 2017 merger agreement the Supreme Court in the U.S. state of Delaware today ruled in favor of Fresenius. As this is the highest Court in Delaware, no further appeal is possible.

Fresenius terminated the merger agreement due to Akorn’s failure to fulfill several closing conditions. An independent investigation initiated by Fresenius had revealed, among other things, material breaches of FDA data integrity requirements relating to Akorn's operations. Akorn responded by suing in the Court of Chancery in Delaware for the consummation of the agreement but Akorn’s lawsuit had been dismissed by the Court of Chancery of Delaware in the first instance as well as now in the second and last instance before the Delaware Supreme Court.

Fresenius Kabi has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration (FDA). The FDA recognized the role Fresenius Kabi played in helping mitigate a shortage of IV saline, specifically Sodium Chloride Injection USP, 0.9% in bags. The shortage was caused last year by supply disruptions at manufacturers affected by Hurricane Maria.  The hurricane devastated Puerto Rico, where many companies produce medicines for U.S. hospitals.

Fresenius Kabi has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration (FDA). The FDA recognized the role Fresenius Kabi played in helping mitigate a shortage of IV saline, specifically Sodium Chloride Injection USP, 0.9% in bags. The shortage was caused last year by supply disruptions at manufacturers affected by Hurricane Maria.  The hurricane devastated Puerto Rico, where many companies produce medicines for U.S. hospitals.

Arsenic Trioxide Injection is the newest addition to the company’s oncology portfolio.

Fresenius Kabi HYDROmorphone Hydrochloride injection is a new offering for the company, expanding its analgesia and anesthesia portfolio. It is available in six single-dose vial presentations.

Palonosetron Hydrochloride Injection is now available in the U.S. and is the newest product in the company’s Simplist™ prefilled syringe portfolio.  It is an antiemetic used to manage chemotherapy-induced nausea and vomiting. Fresenius Kabi is the first company to offer U.S. customers Palonosetron Hydrochloride in a ready-to-administer syringe.

Fresenius Kabi has launched Heparin Sodium injection in ready-to-administer non-DEHP freeflex^® bags, expanding the company’s critical care portfolio. Fresenius Kabi offers a comprehensive portfolio of Heparin Sodium in the U.S. with multiple vial presentations, a pre-filled syringe and bag presentations.

Fresenius Kabi has signed a worldwide settlement and license agreement with AbbVie, settling all pending patent litigations between the two companies. Under the terms of the agreement and subject to marketing authorization by the health authorities, Fresenius Kabi’s biosimilar candidate of Humira^®1 (adalimumab), MSB11022², could be commercialized in the United States from September 30, 2023.

On October 17, 2018 licenses under the agreement came into effect in certain countries in Europe in which AbbVie owns intellectual property. The application for marketing authorization for MSB11022 was submitted by Fresenius Kabi to the European Medicines Agency (EMA) at the end of last year. The dossier is currently under review. A first launch in Europe is expected in the first half of 2019.

¹ Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.

² MSB11022 is being developed as a biosimilar candidate of Humira® and is not yet approved by health authorities.