LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi USA announced today it has introduced the anti-infective Moxifloxacin Injection 400 mg per 250 mL in Freeflex® bags. This is a first-to-market alternative for this injectable drug which had previously been available only from the innovator.
Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition.
Moxifloxacin is the third premix product Fresenius Kabi has introduced in the United States since 2013 using the company’s proprietary Freeflex delivery system. Freeflex is a non-PVC and non-DEHP flexible bag for infusion solutions using patented port technology and clear labeling.
"Fresenius Kabi is pleased to offer this first and only alternative to Avelox Injection for our customers and the patients they serve,” said John Ducker, president and CEO of Fresenius Kabi USA. “The introduction of Moxifloxacin expands both our leading anti-infective portfolio and our ready-to-use intravenous offerings in the U.S."
Moxifloxacin Injection Important Safety Information (ISI)
BOXED WARNING:
WARNING: TENDON EFFECTS and MYASTHENIA GRAVIS
See full prescribing information for complete boxed warning
Fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs.
Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis.
Indications and Usage
Moxifloxacin injection is indicated for the treatment of adults (18 years of age or older) with infections caused by susceptible isolates of the designated microorganisms in the conditions listed below.
· Acute Bacterial Sinusitis
· Acute Bacterial Exacerbation of Chronic Bronchitis
· Community Acquired Pneumonia
· Uncomplicated Skin and Skin Structure Infections
· Complicated Skin and Skin Structure Infections
· Complicated Intra-Abdominal Infections
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA Vigilance & Medical Affairs at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including BOXED WARNING, available at www.fresenius-kabi.us.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in lifesaving 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.
Avelox® is a registered trademark of Bayer Aktiengesellschaft and is used under license by Schering Corporation, a subsidiary of Merck & Co., Inc.
