Treats cervical dystonia. BLA 761127, held by Revance Therapeutics, Inc.. Daxibotulinumtoxina-Lanm.
As of Nov 14, 2026, BLA 761127 (Daxxify), held by Revance Therapeutics, Inc., was first approved by FDA on Sep 7, 2022, with 1 approved supplement and 1 published complete response letter.
DAXXIFY is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/ or procerus muscle activity in adult patients. The treatment of cervical dystonia in adult patients. 1.1 Glabellar Lines DAXXIFY 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. 1.2 Cervical Dystonia DAXXIFY is indicated for the treatment of cervical dystonia in adult patients.
| Aug 11, 2023 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 7, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 14, 2021 | DaxibotulinumtoxinAProduct Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daxxify0.1ML · injectable;intramuscular, subcutaneous | Daxibotulinumtoxina-Lanm | Rx |
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
