FDA — authorised 16 May 2003
- Application: NDA021455
- Marketing authorisation holder: HOFFMANN LA ROCHE
- Local brand name: BONIVA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ibandronate in United States
FDA authorised Ibandronate on 16 May 2003 · 2,819 US adverse-event reports
Marketing authorisations
FDA — authorised 6 January 2006
- Application: NDA021858
- Marketing authorisation holder: ROCHE
- Local brand name: BONIVA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 19 March 2012
- Application: ANDA078998
- Marketing authorisation holder: ORBION PHARMS
- Status: supplemented
FDA — authorised 30 April 2012
- Application: ANDA078997
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: supplemented
FDA — authorised 2 September 2014
- Application: ANDA202671
- Marketing authorisation holder: PHARMOBEDIENT
- Status: supplemented
FDA — authorised 19 August 2015
- Application: ANDA205332
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 31 October 2017
- Application: ANDA206887
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: supplemented
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: 27 March 2025 – 27 March 2026
- Total reports: 2,819
Most-reported reactions
- Arthralgia — 365 reports (12.95%)
- Nausea — 321 reports (11.39%)
- Diarrhoea — 319 reports (11.32%)
- Femur Fracture — 293 reports (10.39%)
- Headache — 282 reports (10%)
- Fatigue — 261 reports (9.26%)
- Fall — 256 reports (9.08%)
- Pain — 253 reports (8.97%)
- Pain In Extremity — 247 reports (8.76%)
- Back Pain — 222 reports (7.88%)
Ibandronate 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 Ibandronate approved in United States?
Yes. FDA authorised it on 16 May 2003; FDA authorised it on 6 January 2006; FDA authorised it on 19 March 2012.
Who is the marketing authorisation holder for Ibandronate in United States?
HOFFMANN LA ROCHE holds the US marketing authorisation.