FDA
- Status: approved
🇺🇸 SOLE in United States
SOLE (SOLE) regulatory status in United States.
Marketing authorisation
SOLE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is SOLE approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for SOLE in United States?
The University of Texas Health Science Center, Houston is the originator. The local marketing authorisation holder may differ — check the official source linked above.