FDA — authorised 15 April 2014
- Application: BLA125431
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: TANZEUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Albugon on 15 April 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 April 2014; FDA has authorised it.
GLAXOSMITHKLINE LLC holds the US marketing authorisation.