FDA — authorised 17 September 1996
- Application: NDA020586
- Marketing authorisation holder: OTSUKA AMERICA
- Local brand name: BREATHTEK UBT FOR H-PYLORI
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Hyperpolarized 13C,15N2-urea in United States
FDA authorised Hyperpolarized 13C,15N2-urea on 17 September 1996
Marketing authorisations
FDA — authorised 4 February 1999
- Application: NDA020900
- Marketing authorisation holder: DXS DEVICES
- Local brand name: PYLORI-CHEK BREATH TEST
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 17 December 1999
- Application: NDA021092
- Marketing authorisation holder: METABOLIC SOLUTIONS
- Local brand name: HELICOSOL
- Indication: FOR SOLUTION — ORAL
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Hyperpolarized 13C,15N2-urea approved in United States?
Yes. FDA authorised it on 17 September 1996; FDA authorised it on 4 February 1999; FDA authorised it on 17 December 1999.
Who is the marketing authorisation holder for Hyperpolarized 13C,15N2-urea in United States?
OTSUKA AMERICA holds the US marketing authorisation.