FDA Announces New Approval of Daptomycin For Injection in Adult Patients

Fresenius Kabi has announced that the US Food and Drug Administration (FDA) has approved the abbreviated new drug application of daptomycin for injection as an antibiotic and generic alternative to Cubicin.

Daptomycin for injection will be available as a single dose vial containing 500 mg lyophilized powder for reconstitution per vial, providing patients with an additional source of this antibiotic.

The lipopeptide antibacterial is indicated for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactlae, Streptococcus dysgalactlae subsp. equisimills and Enterococcus faecalis in adult patients and Staphylococcus aureus bloodstream infections in adult patients, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

"The approval provides Fresenius Kabi and its customers an additional source of this important antibiotic," the statement said.

Daptomycin is available immediately for those in the US and will be offered as a Novaplus private-label option for Vizient, Inc. members.

The most common adverse reactions in adult cSSSI patients for injection 4 mg/kg (≥2%) are diarrhea, headache, dizziness, rash abnormal liver function tests, elevated CPK, urinary tract infections, hypotension and dyspnea.

Common side-affects in adults with Staphylococcus 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 creatinine phosphokinase and hypertension.

Daptomycin for injection is not indicated for treatment of pneumonia, left-sided infective endocarditis due to Staphylococcus aureus or recommended in pediatric patients younger than 1 year of age due to risk of potential effects on muscular, neuromuscular and/or nervous systems observed in neonatal dogs.

To maintain the effectiveness of Daptomycin for injection and other antibacterial drugs and reduce development of drug-resistant bacteria, the treatment should only be used for infections that are proven or strongly suspected to be caused by bacteria.

Fresenius Kabi also offers daptomycin for injection that’s produced by a third party under a separate, previously approved abbreviated new drug application.