Fresenius Kabi, a global health care company, has received US FDA approval for daptomycin for injection and the product is available immediately for customers in the United States. Daptomycin for injection is an antibiotic and a generic alternative to Cubicin.
The US Food and Drug Administration approved Fresenius Kabi’s ANDA for daptomycin on April 11, 2018. The approval provides Fresenius Kabi and its customers an additional source of this important antibiotic. Fresenius Kabi also offers daptomycin for injection produced by a third party under a separate, previously approved ANDA.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
Fresenius Kabi will also offer this daptomycin as a Novaplus private-label option for Vizient, Inc. members.
Fresenius Kabi daptomycin for injection is available as a single dose vial containing 500 mg per vial. Fresenius Kabi introduced daptomycin for injection to US customers in 2016 under a third-party manufacturing agreement and will continue to offer customers this original version in addition to the new product introduced today.
Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: Complicated skin and skin structure infections (cSSSI) in adult patients; Staphylococcus aureus bloodstream infections (bacteremia) in adult patients, including those with right-sided infective endocarditis.
Limitations of use: Daptomycin for injection is not indicated for the treatment of pneumonia; Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus; Daptomycin for injection is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Daptomycin for Injection and other antibacterial drugs, Daptomycin for Injection should be used to treat infections that are proven or strongly suspected to be caused by bacteria.