Fresenius Kabi Introduces Tigecycline for Injection, USP
First-to-market alternative to TYGACIL® (tigecycline) for injection now available
December 5, 2016
LAKE ZURICH, Ill. December 5, 2016 – Fresenius Kabi announced today the immediate availability in the United States of Tigecycline for Injection, USP. Fresenius Kabi Tigecycline for Injection is available as a single dose vial containing 50 mg Tigecycline. Fresenius Kabi is the first company to introduce in the U.S. market an alternative to the brand TYGACIL®.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
“Fresenius Kabi is pleased to strengthen its antibiotic injectable portfolio with the addition of Tigecycline,” said John Ducker, president and CEO of Fresenius Kabi USA. “It has been satisfying to introduce so many new high-quality, essential products in 2016, especially those such as Tigecycline which has been on drug shortage lists and is used to treat patients with very serious infections for whom there are few or no other treatment options.”
Tigecycline for Injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for the treatment of: complicated skin and skin structure infections; complicated intra-abdominal infections; and community acquired bacterial pneumonia. Tigecycline for Injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia or ventilator-acquired pneumonia.
Warning: All-Cause Mortality
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage (1.4), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)].
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.
TYGACIL® is a trademark of WYETH LLC. Wyeth is a subsidiary of Pfizer Inc.