FDA
- Status: approved
Balance, Fresenius Medical Care, Germany (Balance, Fresenius Medical Care, Germany) 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.
Kyungpook National University Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.