FDA — authorised 7 February 2017
- Application: NDA208325
- Marketing authorisation holder: KAI PHARMS INC
- Local brand name: PARSABIV
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 [¹⁴C]Etelcalcetide in United States
FDA authorised [¹⁴C]Etelcalcetide on 7 February 2017
Marketing authorisation
[¹⁴C]Etelcalcetide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is [¹⁴C]Etelcalcetide approved in United States?
Yes. FDA authorised it on 7 February 2017.
Who is the marketing authorisation holder for [¹⁴C]Etelcalcetide in United States?
KAI PHARMS INC holds the US marketing authorisation.