FDA
- Status: approved
MDD diagnosis and Fluoxetine treatment (MDD diagnosis and Fluoxetine treatment) 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.
University of Pennsylvania is the originator. The local marketing authorisation holder may differ — check the official source linked above.