FDA — authorised 19 October 2007
- Marketing authorisation holder: GENZYME
- Status: approved
🇺🇸 Renvela in United States
FDA authorised Renvela on 19 October 2007
Marketing authorisations
FDA — authorised 29 September 2017
- Application: ANDA206094
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 28 November 2017
- Application: ANDA207288
- Marketing authorisation holder: AMNEAL PHARMS CO
- Status: approved
FDA — authorised 25 March 2020
- Application: ANDA207624
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 10 April 2024
- Application: ANDA206100
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
The FDA approved Renvela, a drug product, on 2024-04-10. The marketing authorisation holder is MACLEODS PHARMS LTD. The approval was granted through a standard expedited pathway. The indication approved is for labeling.
FDA — authorised 25 April 2024
- Application: ANDA207291
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Renvela in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology 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 29 September 2017; FDA authorised it on 28 November 2017.
Who is the marketing authorisation holder for Renvela in United States?
GENZYME holds the US marketing authorisation.