Fresenius Kabi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for MSB11022 a biosimilar candidate of Humira® (adalimumab)*. The European Commission (EC) will now decide on the approval of MSB11022 which is expected in Q2/ 2019.
*Humira® is a registered trademark of AbbVie Biotechnology Ltd.
Fresenius Kabi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for MSB11022 a biosimilar candidate of Humira® (adalimumab)*. The European Commission (EC) will now decide on the approval of MSB11022 which is expected in Q2/ 2019.
*Humira® is a registered trademark of AbbVie Biotechnology Ltd.
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.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
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.