The FDA's drug approvals database lists a supplement, dated 15 September, to Sandoz's abbreviated new drug application for tigecycline (ANDA091620). The record does not describe what the supplement changes; supplements to generic applications usually concern manufacturing, labelling alignment with the reference product, or packaging.
Tigecycline is an intravenous glycylcycline kept for complicated skin, intra-abdominal and some resistant infections. Its label carries a boxed warning about higher all-cause mortality than comparators in pooled trials, which is why it is generally reserved for situations where alternatives are unsuitable. Nothing in this supplement changes that position.
- This is an administrative supplement to a generic licence, not a new indication or safety finding.
- Tigecycline remains a reserve agent because of its boxed mortality warning.
- Check local formulary and resistance data before choosing tigecycline over alternatives.
Why it matters
Generic supply of reserve antibiotics affects access, but this record carries no new clinical information.
Don't overread it
A supplement to a generic application is not an approval of anything new.
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