FDA — authorised 16 May 2003
- Application: NDA021455
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: BONIVA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Boniva in United States
FDA authorised Boniva on 16 May 2003
Marketing authorisations
FDA — authorised 6 January 2006
- Application: NDA021858
- Marketing authorisation holder: ROCHE
- Local brand name: BONIVA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Boniva in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Boniva approved in United States?
Yes. FDA authorised it on 16 May 2003; FDA authorised it on 6 January 2006; FDA has authorised it.
Who is the marketing authorisation holder for Boniva in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.