FDA — authorised 14 September 1992
- Marketing authorisation holder: ORTHO BIOTECH
- Status: approved
FDA authorised Orthoclone Okt3 on 14 September 1992
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 14 September 1992.
ORTHO BIOTECH holds the US marketing authorisation.