FDA — authorised 6 November 1997
- Marketing authorisation holder: OTSUKA
- Status: approved
FDA authorised Tomefloxacin on 6 November 1997
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 November 1997.
OTSUKA holds the US marketing authorisation.