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FDA Approves Daptomycin for Injection in Adult Patients
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Officials with the FDA have approved the abbreviated new drug application of daptomycin for injection as an antibiotic and generic alternative to Cubicin.
Officials with the FDA have 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.
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