FDA
- Status: approved
GSK1838262 600 mg (GSK1838262 600 mg) 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.
XenoPort, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.