Pipeline › albiglutide › Tanzeum
Tanzeum
Tanzeum is a brand of albiglutide from GlaxoSmithKline, first approved by the FDA on 2014-04-15 under application BLA125431, not separately authorised in the European Union under this name, with no open FDA supply records.
Tanzeum is GlaxoSmithKline's brand of albiglutide, approved under BLA125431. Nothing under this name is currently on the FDA shortage list.
- Active ingredient
- albiglutide
- Sponsor
- GlaxoSmithKline
- FDA applications
- BLA125431
- First FDA action
- 2014-04-15
- Most recent FDA action
- 2017-12-20
- FDA actions on file
- 8
- EU authorisation
- Not under this name
- Active trials of albiglutide
- 0
FDA record
Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.
| Date | Action | Application |
|---|---|---|
| 2017-12-20 | Labeling | BLA125431 · label |
| 2017-12-12 | REMS | BLA125431 · label |
| 2017-08-01 | Labeling | BLA125431 · label |
| 2016-09-13 | Labeling | BLA125431 · label |
| 2015-07-27 | REMS | BLA125431 · label |
| 2015-05-07 | Labeling | BLA125431 · label |
| 2015-03-09 | Labeling | BLA125431 · label |
| 2014-04-15 | Type 1 - New Molecular Entity original | BLA125431 · label |
For the molecule behind this brand — every trial, every indication under study and the full research record — see albiglutide.