Prabotulinumtoxina-Xvfs

Sold as Jeuveau. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Prabotulinumtoxina-Xvfs (sold as Jeuveau), first approved Feb 1, 2019, with 0 new uses approved and 1 published complete response letter.

First approved: Feb 1, 2019
Applications: 1
New uses approved: 0
Complete response letters: 1

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
BoTox Into the Sternocleidomastoid Muscles (SCM)Neck Muscle Issue · Boston Medical Center	Phase 4	Recruiting	Apr 1, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Feb 1, 2019	JeuveauBLA 761085 · New molecular entity	Evolus Inc	1	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
May 15, 2018	Otulinum toxin Type AProduct Quality	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA