BLA 125431, held by Glaxosmithkline LLC. Albiglutide.
As of Nov 14, 2026, BLA 125431 (Tanzeum), held by Glaxosmithkline LLC, was first approved by FDA on Apr 15, 2014, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tanzeum30MG · injectable;injection | Albiglutide | Discontinued |
| Dec 20, 2017 | Supplement 20Labeling · Standard review | Approved | |
| Dec 12, 2017 | Supplement 21REMS | Approved | |
| Aug 1, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Sep 13, 2016 | Supplement 18Labeling · Standard review | Approved | |
| Jul 27, 2015 | Supplement 14REMS | Approved | |
| May 7, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Mar 9, 2015 | Supplement 8Labeling | Approved | |
| Apr 15, 2014 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
