FDA — authorised 20 August 2001
- Application: NDA021223
- Marketing authorisation holder: NOVARTIS
- Local brand name: ZOMETA
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
🇺🇸 Zoledronic acid in combination with therapy in United States
FDA authorised Zoledronic acid in combination with therapy on 20 August 2001
Marketing authorisations
FDA — authorised 22 February 2002
- Application: NDA021386
- Marketing authorisation holder: NOVARTIS
- Local brand name: ZOMETA
- Indication: INJECTABLE — IV (INFUSION)
- Status: approved
FDA — authorised 16 April 2007
- Application: NDA021817
- Marketing authorisation holder: SANDOZ
- Local brand name: RECLAST
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 August 2007
- Application: NDA022080
- Marketing authorisation holder: SANDOZ
- Local brand name: RECLAST
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Zoledronic acid in combination with therapy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Zoledronic acid in combination with therapy approved in United States?
Yes. FDA authorised it on 20 August 2001; FDA authorised it on 22 February 2002; FDA authorised it on 16 April 2007.
Who is the marketing authorisation holder for Zoledronic acid in combination with therapy in United States?
NOVARTIS holds the US marketing authorisation.