FDA — authorised 28 April 2009
- Application: ANDA078809
- Marketing authorisation holder: CARDINAL HEALTH 414
- Local brand name: TECHNETIUM TC 99M SESTAMIBI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Technetium Tc 99M Sestamibi in United States
FDA authorised Technetium Tc 99M Sestamibi on 28 April 2009
Marketing authorisations
FDA — authorised 29 April 2009
- Application: ANDA078806
- Marketing authorisation holder: JUBILANT DRAXIMAGE
- Local brand name: TECHNETIUM TC 99M SESTAMIBI
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 2009
- Application: ANDA079157
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: TECHNETIUM TC 99M SESTAMIBI
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Marketing authorisation holder: CURIUM
- Status: approved
Technetium Tc 99M Sestamibi 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 Technetium Tc 99M Sestamibi approved in United States?
Yes. FDA authorised it on 28 April 2009; FDA authorised it on 29 April 2009; FDA authorised it on 10 July 2009.
Who is the marketing authorisation holder for Technetium Tc 99M Sestamibi in United States?
CARDINAL HEALTH 414 holds the US marketing authorisation.