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, companies, and clinical use contexts without reconstructing the record across separate labels and approval letters.
Dataset Boundary
Section titled “Dataset Boundary”As of August 10, 2026, this version covers U.S.-visible products in the current brand graph: Botox / Botox Cosmetic, Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, and Letybo. It does not include products with pending, refused, or otherwise unresolved U.S. applications unless they enter the FDA approval record.
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
Section titled “Original Product Approval Anchors”| Date | Brand / product | Nonproprietary name | Approval type | Indication / context | Company relationship | Primary source |
|---|---|---|---|---|---|---|
| December 29, 1989 | Botox | OnabotulinumtoxinA | Original U.S. therapeutic approval anchor | FDA orphan-drug records list December 29, 1989 for strabismus and December 30, 1989 for blepharospasm; the current label preserves 1989 as the initial U.S. approval year. | Allergan heritage; now AbbVie / Allergan | FDA orphan-drug record 🔗; current U.S. label 🔗 |
| 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
Section titled “Major Indication Expansions”| Date | Brand / product | Nonproprietary name | Approval type | Indication / context | Company relationship | Primary 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 🔗 |
| July 2024 | Xeomin | IncobotulinumtoxinA | Aesthetic indication expansion | Temporary improvement in the appearance of moderate to severe upper facial lines in adults: glabellar lines, horizontal forehead lines, and lateral canthal lines / crow’s feet, treated individually or simultaneously within the label. | Merz Pharma | FDA approval letter 🔗; FDA 2024 label PDF 🔗 |
| October 2024 | Botox Cosmetic | OnabotulinumtoxinA | Aesthetic indication expansion | Temporary improvement in the appearance of moderate to severe platysma bands associated with platysma muscle activity in adults; the current FDA label identifies the indication and the October 2024 major-change month. | Allergan heritage; now AbbVie / Allergan | FDA 2024 label PDF 🔗 |
| June 26, 2026 | Xeomin | IncobotulinumtoxinA | Pediatric indication-boundary expansion | Treatment of upper limb spasticity in patients 2 years of age and older now includes pediatric patients with spasticity associated with cerebral palsy; the earlier label excluded that population because of another product’s marketing exclusivity. | Merz Pharma | FDA June 2026 approval label 🔗; Merz announcement, June 26, 2026 🔗 |
What the Approval Sequence Establishes
Section titled “What the Approval Sequence Establishes”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, multi-area facial labeling, neck aesthetic labeling, and expanded pediatric spasticity coverage. 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
Section titled “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. An official manufacturer announcement is used alongside the June 2026 FDA approval label to establish the June 26 date of the Xeomin pediatric label update. FDA approval records and linked label materials were last checked on August 10, 2026. DailyMed remains useful for current label access, but FDA sources are preferred for the approval timeline itself.