The FDA recorded a supplement dated 15 September 2026 to Sandoz's abbreviated new drug application for tigecycline, the intravenous glycylcycline. The record does not state the nature of the supplement. Supplements to generic applications usually concern manufacturing, labelling alignment with the reference product, or packaging.
Tigecycline is already available generically, including in India. This action does not add an indication or change safety guidance on its own. It is a reminder that tigecycline carries a boxed warning for increased all-cause mortality compared with other antibiotics, and should be kept for situations where alternatives are unsuitable.
- This is a supplement to an existing generic application, not a new approval or indication.
- Tigecycline carries an FDA boxed warning for higher all-cause mortality than comparator antibiotics.
- Reserve tigecycline for infections where suitable alternatives are unavailable, guided by susceptibility.
- Do not use tigecycline for bloodstream infection as monotherapy; serum levels are low.
Why it matters
It keeps a last-line agent in view, where the prescribing rule matters more than the regulatory action.
Don't overread it
A licence supplement to a generic is not a new indication or a safety finding.
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