FDA — authorised 5 June 1958
- Application: NDA011287
- Marketing authorisation holder: CONCORDIA
- Local brand name: KAYEXALATE
- Indication: POWDER — ORAL, RECTAL
- Status: approved
FDA authorised Sodium Polystyrene Sulfonate Oral Suspension [SPS] on 5 June 1958
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 5 June 1958; FDA has authorised it.
CONCORDIA holds the US marketing authorisation.