Generic Approval Increases Availability of Antibiotic Used for Serious Infections
Fresenius Kabi announced the availability of Tigecycline for Injection, a generic version of Pfizer's Tygacil, in single-dose vials containing 50mg of tigecycline.
Tigecycline is a tetracycline class antibacterial indicated in patients ≥18 years for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. The drug carries a black box warning regarding an increased risk of all-cause mortality associated with treatment, as such, it should be reserved for use in situations when alternative treatments are not suitable.
CEO of Fresenius Kabi USA, James Ducker, said he is pleased with the company's output 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.
A shortage in Tygacil was posted initially in December 2015 to the Food and Drug Administration (FDA) website. Currently, Tygacil 50mg/5mL vials are available, however the 50mg/10mL vials are not expected to be available until the first quarter of 2017.
For more information visit Fresenius-kabi.us.