The candidate vaccine’s next steps will be going through the FDA’s Biologics License Application process.
|Articles|October 20, 2003
First in new class of antibiotics gets FDA nod
Clinicians will soon be able to treat serious bacterial infections using the first cyclic lipopeptide agent to receive FDA approval. The FDA recently approved daptomycin (Cubicin, Cubist Pharmaceuticals) for injection for the treatment of complicated skin and skin structure infections caused by susceptible strains of Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-resistant strains only). Daptomycin is not indicated for the treatment of pneumonia. According to the manufacturer, daptomycin is expected to be available in hospitals in early November.
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