LAKE ZURICH, Ill., April 12, 2018 – Fresenius Kabi announced today it has received 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 U.S. 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 U.S. 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.
About Daptomycin for Injection
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.
Important Safety Information
Daptomycin for Injection is contraindicated in patients with known hypersensitivity to daptomycin.
Anaphylaxis/hypersensitivity reactions (including life-threatening): discontinue Daptomycin for Injection and treat signs/symptoms.
Myopathy and rhabdomyolysis: Monitor creatinine phosphokinase (CPK) levels and follow muscle pain or weakness. Consider discontinuation of Daptomycin if elevated CPK or myopathy occurs.
Eosinophilic pneumonia: Discontinue Daptomycin for Injection and consider systemic steroids.
Peripheral neuropathy: Monitor for neuropathy and consider discontinuation.
Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
Persisting or relapsing S. aureus bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection.
Decreased efficacy was observed in adult patients with moderate baseline renal impairment.
The most common adverse reactions in adult cSSSI patients receiving Daptomycin for Injection 4 mg/kg (≥2%) are diarrhea, headache, dizziness, rash, abnormal liver function tests, elevated CPK, urinary tract infections, hypotension, and dyspnea.
The most common adverse reactions in adult patients with S. aureus bacteremia/endocarditis receiving Daptomycin for Injection 6 mg/kg (≥5%) are sepsis, bacteremia, abdominal pain, chest pain, edema, pharyngolaryngeal pain, pruritic, increased sweating, insomnia, elevated CPK and hypertension.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Daptomycin for Injection safely and effectively. Please click on https://tinyurl.com/yc67rn9f for the full prescribing information for Daptomycin for Injection or visit www.fresenius-kabi.com/us.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/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.