U.S. FDA approval timeline

The U.S. approval history for botulinum toxin products is a product-specific regulatory record, not a ranking system. An earlier approval date does not establish clinical superiority, and a shared toxin type does not make units interchangeable, labels identical, or products substitutable.

This timeline tracks major U.S. FDA approval anchors for the botulinum toxin brands currently represented in the index. It emphasizes original product approvals and selected indication expansions that help readers connect brands, manufacturers, and clinical use contexts without reconstructing the record across separate labels and approval letters.

Approval history is not equivalence

FDA approval records define product- and indication-specific regulatory history in the United States. They do not show that botulinum toxin products have equivalent units, identical dosing, the same approved uses, or superior clinical performance.

Dataset Boundary

This first version covers U.S.-visible products in the current brand graph: Botox / Botox Cosmetic, Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, and Letybo.

The table is not a complete label-change database. It records major approval anchors that are useful for interpreting the current site graph. Current prescribing information remains the authority for approved uses, preparation, warnings, dosing language, and patient populations.

Original Product Approval Anchors

Date	Brand / product	Nonproprietary name	Approval type	Indication / context	Company relationship	FDA source
December 29, 1989	Botox	OnabotulinumtoxinA	Original U.S. therapeutic approval anchor	FDA orphan-drug records list a marketing approval date for botulinum toxin type A / Botox; current labels preserve 1989 as the initial U.S. approval year.	Allergan heritage; now AbbVie / Allergan	FDA orphan-drug record; FDA 2024 label PDF
December 8, 2000	Myobloc	RimabotulinumtoxinB	Original U.S. product approval	Treatment of cervical dystonia to reduce severity of abnormal head position and neck pain associated with cervical dystonia.	Approved to Elan Pharmaceuticals; current U.S. commercial context sits with Supernus Pharmaceuticals	FDA approval letter
April 29, 2009	Dysport	AbobotulinumtoxinA	Original U.S. product approval package	Cervical dystonia and glabellar-line approval anchors entered the U.S. record through the 2009 Dysport BLA package.	Ipsen product context; Galderma aesthetic commercialization context in licensed territories	FDA approval package; FDA approval letter
July 30, 2010	Xeomin	IncobotulinumtoxinA	Original U.S. product approval	Adult cervical dystonia and adult blepharospasm in previously treated patients.	Merz Pharma	FDA approval letter
February 1, 2019	Jeuveau	PrabotulinumtoxinA-xvfs	Original U.S. product approval	Temporary improvement in the appearance of moderate to severe glabellar lines in adults.	Evolus commercialization; Daewoong Pharmaceutical manufacturing identity	FDA approval letter; FDA label PDF
September 7, 2022	Daxxify	DaxibotulinumtoxinA-lanm	Original U.S. product approval	Temporary improvement in the appearance of moderate to severe glabellar lines in adults.	Developed by Revance; current ownership context sits with Revance / Crown Laboratories	FDA Drug Trials Snapshot; FDA approval package
February 29, 2024	Letybo	LetibotulinumtoxinA-wlbg	Original U.S. product approval	Temporary improvement in the appearance of moderate to severe glabellar lines in adults.	Hugel	FDA Drug Trials Snapshot; FDA 2024 label PDF

Major Indication Expansions

Date	Brand / product	Nonproprietary name	Approval type	Indication / context	Company relationship	FDA source
April 12, 2002	Botox Cosmetic	OnabotulinumtoxinA	Aesthetic indication expansion and market-label anchor	Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults under the 2002 approval language.	Allergan heritage; now AbbVie / Allergan	FDA approval letter
October 15, 2010	Botox	OnabotulinumtoxinA	Therapeutic indication expansion	Prophylaxis of headaches in adults with chronic migraine.	Allergan heritage; now AbbVie / Allergan	FDA approval package letter; FDA approval letter
July 2011	Xeomin	IncobotulinumtoxinA	Aesthetic indication expansion	Temporary improvement in the appearance of moderate to severe glabellar lines in adults; the FDA label-change anchor identifies the change by month.	Merz Pharma	FDA label-change anchor
September 11, 2013	Botox Cosmetic	OnabotulinumtoxinA	Aesthetic indication expansion	Temporary improvement in the appearance of moderate to severe lateral canthal lines, commonly discussed as crow’s feet.	Allergan heritage; now AbbVie / Allergan	FDA approval letter; FDA 2013 label PDF
August 11, 2023	Daxxify	DaxibotulinumtoxinA-lanm	Therapeutic indication expansion	Treatment of cervical dystonia in adult patients.	Developed by Revance; current ownership context sits with Revance / Crown Laboratories	FDA approval letter; FDA orphan-drug approval record

Reading the Timeline

The approval sequence shows how U.S. botulinum toxin history moved from therapeutic neurology and ophthalmology into aesthetic labeling, then into a broader set of branded type A products. It also shows why one page cannot replace product-specific labels. A product can have a narrow aesthetic approval, a broader therapeutic label, a later indication expansion, or a company relationship that changed after approval.

For product comparison, start with the brand page, then check the current FDA prescribing information. For clinical-use interpretation, use indication pages as context, not as approval tables. For company interpretation, separate the approval holder, manufacturer, commercialization partner, and later owner where those facts differ.

Sources

This dataset uses FDA approval letters, FDA approval packages, FDA label PDFs, FDA Drug Trials Snapshots, and FDA orphan-drug records where those records clarify an approval date or indication. FDA approval records and linked label materials were last checked on June 8, 2026. DailyMed remains useful for current label access, but FDA sources are preferred for the approval timeline itself.