The FDA recorded a supplement on 15 September 2026 to abbreviated new drug application 214020, Meitheal's generic tigecycline. The record does not state the nature of the supplement; changes of this kind to a generic application typically concern manufacturing, labelling or packaging rather than a new indication.
Tigecycline itself is unchanged. It remains a reserve agent for complicated skin, soft-tissue and intra-abdominal infection where alternatives are unsuitable, and it carries an FDA boxed warning for increased all-cause mortality compared with other antibiotics.
The record is administrative. It is noted here because it is the only regulatory activity on this desk today.
- No change to tigecycline's indications or warnings follows from this record
- Keep tigecycline as a reserve agent where alternatives are unsuitable
- Remember the boxed warning for increased all-cause mortality
- Avoid tigecycline for bloodstream infection — its serum levels are low
Why it matters
It confirms continued generic supply of a reserve antibiotic, without any new safety or efficacy information.
Don't overread it
A supplement to a generic application is not a new indication or a safety finding.
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