FDA — authorised 19 October 2007
- Application: NDA022127
- Marketing authorisation holder: SANOFI
- Status: supplemented
🇺🇸 Renvela in United States
FDA authorised Renvela on 19 October 2007 · 8,217 US adverse-event reports
Marketing authorisations
FDA — authorised 12 August 2009
- Application: NDA022318
- Marketing authorisation holder: GENZYME
- Status: supplemented
FDA — authorised 17 July 2017
- Application: ANDA207179
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 2018
- Application: ANDA200959
- Marketing authorisation holder: ARTHUR GRP
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 2018
- Application: ANDA210464
- Marketing authorisation holder: DR REDDYS
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 November 2018
- Application: ANDA204451
- Marketing authorisation holder: RISING
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 August 2020
- Application: ANDA201069
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 November 2020
- Application: ANDA211316
- Marketing authorisation holder: IMPAX
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 May 2021
- Application: ANDA209374
- Marketing authorisation holder: BIONPHARMA
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 December 2021
- Application: ANDA201513
- Marketing authorisation holder: LUPIN
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA217319
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA206234
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: SEVELAMER CARBONATE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 October 2024
- Application: ANDA215998
- Marketing authorisation holder: SHANDONG XINHUA
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2025
- Application: ANDA219931
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: SEVELAMER CARBONATE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Renvela (Sevelamer Carbonate) for oral tablet use. This approval was granted to Navinta LLC, the marketing authorisation holder, on 27 October 2025. The approval was based on a standard application pathway.
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 8,217
Most-reported reactions
- Constipation — 2,354 reports (28.65%)
- Pruritus — 926 reports (11.27%)
- Diarrhoea — 904 reports (11%)
- Nausea — 732 reports (8.91%)
- Chronic Kidney Disease — 626 reports (7.62%)
- End Stage Renal Disease — 613 reports (7.46%)
- Renal Failure — 604 reports (7.35%)
- Death — 545 reports (6.63%)
- Vomiting — 458 reports (5.57%)
- Acute Kidney Injury — 455 reports (5.54%)
Renvela in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Renvela approved in United States?
Yes. FDA authorised it on 19 October 2007; FDA authorised it on 12 August 2009; FDA authorised it on 17 July 2017.
Who is the marketing authorisation holder for Renvela in United States?
SANOFI holds the US marketing authorisation.