BLA 761204, held by Amicus Therap US. Cipaglucosidase Alfa-Atga.
As of Nov 13, 2026, BLA 761204 (Pombiliti), held by Amicus Therap US, was first approved by FDA on Sep 28, 2023, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 2023 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pombiliti105MG · injectable;injection | Cipaglucosidase Alfa-Atga | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 25, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Sep 28, 2023 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
