FDA — authorised 30 October 1998
- Application: NDA020926
- Marketing authorisation holder: GENZYME
- Local brand name: RENAGEL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 sevelamer phosphate-binders in United States
FDA authorised sevelamer phosphate-binders on 30 October 1998
Marketing authorisations
FDA — authorised 12 July 2000
- Application: NDA021179
- Marketing authorisation holder: GENZYME
- Local brand name: RENAGEL
- Indication: TABLET — ORAL
- Status: approved
sevelamer phosphate-binders 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 sevelamer phosphate-binders approved in United States?
Yes. FDA authorised it on 30 October 1998; FDA authorised it on 12 July 2000.
Who is the marketing authorisation holder for sevelamer phosphate-binders in United States?
GENZYME holds the US marketing authorisation.