Fresenius Kabi received a Warning Letter, dated August 16, from the U.S. Food and Drug Administration (FDA) related to an April 2013 inspection of its Fenwal blood bag manufacturing plant in Maricao, Puerto Rico. Fresenius Kabi acquired Fenwal in December 2012.
The Warning Letter observations are primarily related to complaint-handling procedures, labeling issues, and filing of field alerts not in accordance with FDA regulations. The Warning Letter was not issued as a result of adverse events related to patient safety.
Following the inspection, Fresenius Kabi submitted a detailed remediation action plan to the FDA. The company has made significant progress in remedying the issues cited in the Warning Letter including improvements to its procedures and documentation. Production at the plant is continuing.
The company takes this matter very seriously and intends to respond in a timely and comprehensive manner to the Warning Letter. No material sales and earnings impact on Fresenius Kabi's business is expected. Fresenius Kabi fully confirms its 2013 guidance.
A copy of the FDA Warning Letter is attached to this document.
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.
The company's proprietary Freeflex IV containers allow easy handling with enhanced safety. Fresenius Kabi offers the broadest ropivacaine anaesthetics portfolio in the U.S.
According to IMS, Fresenius Kabi’s market share for Propofol and its equivalent, Diprivan, was 73% in November 2014 (October: 73%). Since March 2014, IMS data on our competition has included direct sales to hospitals. Fresenius Kabi does not report direct sales; our market share is therefore not fully reflected in IMS data.
Fresenius Kabi has received FDA approval for Neostigmine Methylsulfate Injection. Neostigmine is used after surgery to reverse the actions of drugs that block nerve and muscle function.
According to IMS, Fresenius Kabi’s market share for Propofol and its equivalent, Diprivan, was 75% in December 2014 (November: 73%). Since March 2014, IMS data on our competition has included direct sales to hospitals. Fresenius Kabi does not report direct sales; our market share is therefore not fully reflected in IMS data.
Argatroban injection expands Kabi's anticoagulant product portfolio. Now available as a 250mg/2.5mL presentation in a single dose vial.
FDA has extended regulatory discretion on sodium chloride infusion solutions (until May 31) and trace elements (until June 30,) but has discontinued discretion to import Glycophos (Dec. 31, 2014). Accordingly, Fresenius Kabi expects lower 2015 sales from products imported under regulatory discretion. Fresenius Kabi expects 2015 IV generic product launches to be backloaded.
Moxifloxacin injection further expands the Fresenius Kabi anti-infective portfolio. It is available in the company's proprietary Freeflex® bag.
Cisatracurium Besylate Injection, a neuromuscular blocker, further expands Fresenius Kabi's anesthesia portfolio. Now available in three presentations.
Glucagon injection expands Fresenius Kabi's U.S. critical care portfolio and is sold in 10-packs of 1mg vials.