BLA 761085, held by Evolus Inc. Prabotulinumtoxina-Xvfs.
As of Nov 13, 2026, BLA 761085 (Jeuveau), held by Evolus Inc, was first approved by FDA on Feb 1, 2019, with 1 approved supplement and 1 published complete response letter.
JEUVEAU is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 2019 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| May 15, 2018 | Otulinum toxin Type AProduct Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jeuveau100 UNITS · injectable;injection | Prabotulinumtoxina-Xvfs | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 12, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Feb 1, 2019 | 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
