The FDA recorded a supplemental approval on 24 September 2026 for Baxter's daptomycin in 0.9% sodium chloride (NDA 213645), a ready-to-use premixed formulation.
The FDA record lists the supplement but does not state what it changes; supplements to an existing application commonly cover labelling, manufacturing or presentation rather than a new indication. Nothing in the record suggests a new safety finding.
For prescribers and pharmacists, the relevant points about daptomycin are unchanged: it is inactivated by pulmonary surfactant and should not be used for pneumonia, creatine kinase should be checked weekly, and statins are usually paused during treatment.
- Do not use daptomycin for pneumonia; surfactant inactivates it.
- Check creatine kinase at baseline and weekly during treatment.
- Consider pausing statins while a patient is on daptomycin.
- Adjust the dosing interval for creatinine clearance below 30 mL/min.
Why it matters
Premixed bags reduce compounding steps on wards that use daptomycin for staphylococcal bacteraemia.
Don't overread it
A licence supplement is not a new indication or a safety finding.
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