FDA
- Status: approved
B55R1 and placebo for B55R2 (B55R1 and placebo for B55R2) 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.
AJU Pharm Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.