FDA
- Status: approved
prescribing anapproved drug, examination (prescribing anapproved drug, examination) regulatory status in United States.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
I.M. Sechenov First Moscow State Medical University is the originator. The local marketing authorisation holder may differ — check the official source linked above.