Expanded Label for IV Antibiotic Daptomycin
Cubist Pharmaceuticals has announced the FDA’s approval of its supplemental New Drug Application for daptomycin for injection (Cubicin) as once-a-day therapy at 6 mg/kg for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections, including right-sided endocarditis caused by methicillin-susceptible S. au-reus (MSSA) and methicillin-resistant S. aureus (MRSA).
Cubist estimates that these infections account for 30,000 deaths in the U.S. alone each year. This is the only IV antibiotic approved for this indication, which was based on the results of a prospective, randomized, controlled registration trial.
singulair 5 mg
The drug was originally approved in 2003, at 4 mg/kg intravenously once daily for the treatment of complicated skin and skin structure infections caused by gram-positive organisms, including both susceptible and resistant strains of S. aureus (MSSA and MRSA, respectively).
Daptomycin is not indicated for patients with pneumonia. For patients with persisting or relapsing S. aureus infection or with a poor clinical response, a second blood culture specimen should be obtained.
