FDA
- Status: approved
Agomelatine or PIacebo (Agomelatine or PIacebo) 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.
Second Affiliated Hospital of Soochow University is the originator. The local marketing authorisation holder may differ — check the official source linked above.