U.S. FDA approval timeline
This timeline brings together major milestones in the U.S. regulatory history of botulinum toxin products, including original product approvals and selected indication expansions. Each entry is anchored to an FDA record for the named product and use.
Dataset Boundary
Section titled “Dataset Boundary”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. Those stages are tracked separately in U.S. botulinum toxin regulatory status.
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 | Indication / context | Company relationship | Primary source |
|---|---|---|---|---|---|
| December 29, 1989 | Botox | OnabotulinumtoxinA | 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 | 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 | 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 | Adult cervical dystonia and adult blepharospasm in previously treated patients. | Merz Pharma | FDA approval letter 🔗 |
| February 1, 2019 | Jeuveau | PrabotulinumtoxinA-xvfs | 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 | 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 | 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 | Indication / context | Company relationship | Primary source |
|---|---|---|---|---|---|
| April 12, 2002 | Botox Cosmetic | OnabotulinumtoxinA | 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 | Prophylaxis of headaches in adults with chronic migraine. | Allergan heritage; now AbbVie / Allergan | FDA approval package letter 🔗; FDA approval letter 🔗 |
| July 2011 | Xeomin | IncobotulinumtoxinA | 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 | 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 20, 2019 | Myobloc | RimabotulinumtoxinB | Treatment of chronic sialorrhea in adults. | Approved to Solstice Neurosciences; current commercial context sits with Supernus Pharmaceuticals | FDA supplement approval letter 🔗 |
| August 11, 2023 | Daxxify | DaxibotulinumtoxinA-lanm | 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 5, 2024 | Xeomin | IncobotulinumtoxinA | 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 | 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 | 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 orphan-drug exclusivity. | Merz Pharma | FDA supplement approval letter 🔗; FDA-approved June 2026 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.
For programs that have a public BLA, CRL, or resubmission history without U.S. approval, use U.S. botulinum toxin regulatory status rather than adding them to this approval sequence.