The FDA drug database lists a supplement dated 24 September 2026 to application NDA 213645 for daptomycin in 0.9% sodium chloride, held by Baxter Healthcare. The record names the product and the applicant. It does not say what the supplement changed, such as labelling, manufacturing or a new indication.
Daptomycin is a lipopeptide antibiotic used against Gram-positive infections including bacteraemia. A supplement to an existing application is a post-approval change and, without the detail, should not be read as a new use or a safety finding.
Check the current FDA label before relying on any change. The position of this product in India, including CDSCO status, is not given in the source.
- The FDA lists a supplement action on NDA 213645, dated 24 September 2026.
- The record does not state what the supplement changed.
- It should not be read as a new indication or safety communication.
- Check the current FDA label for any change before relying on it.
- CDSCO status for this product is not stated in the source.
Why it matters
Regulatory entries are easy to over-read, and this one carries no stated clinical change.
Don't overread it
A licence supplement is not a new indication.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for infectious diseases, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free