FDA — authorised 15 February 2006
- Application: ANDA077266
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
🇺🇸 Paraplatin in United States
FDA authorised Paraplatin on 15 February 2006
Marketing authorisations
FDA — authorised 18 January 2007
- Application: ANDA077861
- Marketing authorisation holder: TEYRO LABS
- Status: approved
FDA — authorised 28 December 2007
- Application: ANDA077269
- Marketing authorisation holder: PHARMACHEMIE BV
- Indication: Labeling
- Status: approved
FDA — authorised 15 February 2017
- Application: ANDA207324
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 8 August 2025
- Application: NDA219921
- Marketing authorisation holder: AVYXA HOLDINGS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Paraplatin for marketing in the United States on August 8, 2025. The approval was granted to AVYXA HOLDINGS under NDA219921. This approval falls under Type 5, which includes new formulations or new manufacturers.
Paraplatin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Paraplatin approved in United States?
Yes. FDA authorised it on 15 February 2006; FDA authorised it on 18 January 2007; FDA authorised it on 28 December 2007.
Who is the marketing authorisation holder for Paraplatin in United States?
FRESENIUS KABI USA holds the US marketing authorisation.