U.S. FDA indication matrix
U.S. botulinum toxin indications are product-specific label claims. A shared indication does not make two products interchangeable, unit-equivalent, identically dosed, equally approved for every patient group, or clinically superior to one another.
As of August 10, 2026, the current U.S. labels represented here are Botox / Botox Cosmetic, Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, and Letybo. The matrix is a regulatory reference, not a dosing guide, treatment recommendation, or therapeutic-equivalence comparison.
Current U.S. Indication Matrix
Section titled “Current U.S. Indication Matrix”| Product | Label scope | Current U.S. labeled indications | Adult / pediatric limits | Current label source / revision |
|---|---|---|---|---|
| Botox / Botox Cosmetic | OnabotulinumtoxinA therapeutic Botox label plus Botox Cosmetic aesthetic label; AbbVie / Allergan company context. | Therapeutic Botox: adult overactive bladder; adult urinary incontinence due to detrusor overactivity associated with a neurologic condition; pediatric neurogenic detrusor overactivity; prophylaxis of headaches in adults with chronic migraine; spasticity; adult cervical dystonia; severe primary axillary hyperhidrosis; blepharospasm; strabismus. Botox Cosmetic: moderate to severe glabellar lines, lateral canthal lines / crow’s feet, forehead lines, and platysma bands. | Pediatric neurogenic detrusor overactivity: 5 years and older. Spasticity: 2 years and older. Blepharospasm and strabismus: 12 years and older. Other therapeutic age limits are indication-specific; Botox Cosmetic indications are for adults. | Botox therapeutic label 🔗 (revised 2/2026); Botox Cosmetic label 🔗 (revised 10/2024) |
| Myobloc | RimabotulinumtoxinB type B therapeutic label; Supernus current company context. | Cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia; chronic sialorrhea. | Adult indications; safety and effectiveness in pediatric patients have not been established. | Myobloc label 🔗 (prescribing information revised 9/2020; DailyMed record updated 10/2025) |
| Dysport | AbobotulinumtoxinA therapeutic and aesthetic label; Ipsen and Galderma relationship context. | Adult cervical dystonia; temporary improvement of moderate to severe glabellar lines; spasticity. | Spasticity: patients 2 years of age and older. Cervical dystonia: adults. Glabellar lines: adults younger than 65 years under the current label wording. | Dysport label 🔗 (revised 9/2023) |
| Xeomin | IncobotulinumtoxinA therapeutic and aesthetic label; Merz Pharma company context. | Chronic sialorrhea; upper limb spasticity; adult cervical dystonia; adult blepharospasm; temporary improvement of upper facial lines in adults, comprising glabellar lines, horizontal forehead lines, and lateral canthal lines / crow’s feet. | Chronic sialorrhea and upper limb spasticity: patients 2 years of age and older. The June 2026 indication change added pediatric upper limb spasticity associated with cerebral palsy to the labeled population. Cervical dystonia, blepharospasm, and upper facial lines: adults. | Current Xeomin label, DailyMed 🔗 (revised 7/2026); FDA June 2026 approval label 🔗 |
| Jeuveau | PrabotulinumtoxinA-xvfs aesthetic label; Evolus commercialization and Daewoong manufacturing context. | Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. | Adult patients. | Jeuveau label 🔗 (revised 4/2023) |
| Daxxify | DaxibotulinumtoxinA-lanm aesthetic and therapeutic label; Revance / Crown company context. | Temporary improvement in the appearance of moderate to severe glabellar lines; treatment of cervical dystonia. | Adult patients. | Daxxify label 🔗 (prescribing information revised 11/2023; DailyMed record updated 1/2026) |
| Letybo | LetibotulinumtoxinA-wlbg aesthetic label; Hugel company context. | Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. | Adult patients. | Letybo label 🔗 (revised 11/2024) |
U.S. Aesthetic Facial-Area Matrix
Section titled “U.S. Aesthetic Facial-Area Matrix”The named treatment area must be checked separately from a product’s general aesthetic visibility. Every type A aesthetic product represented below has a U.S. glabellar-line indication, but only BOTOX Cosmetic and XEOMIN currently include lateral canthal lines, and their broader facial-area labels are not identical.
| Product | Glabellar lines | Lateral canthal lines | Horizontal forehead lines | Platysma bands |
|---|---|---|---|---|
| BOTOX Cosmetic | Yes | Yes | Yes | Yes |
| DYSPORT | Yes | — | — | — |
| XEOMIN | Yes | Yes | Yes | — |
| JEUVEAU | Yes | — | — | — |
| DAXXIFY | Yes | — | — | — |
| LETYBO | Yes | — | — | — |
An em dash means the facial area is not named as an indication in the current U.S. label. It does not mean the product has not been studied, used, or approved for that area elsewhere. The table also does not imply that products sharing a “Yes” have equivalent units, dosing, outcomes, duration, safety, or regulatory wording.
Boey is intentionally outside this U.S. matrix. It is a type E product with Canadian and European Economic Area approval for a specified glabellar-line context, while AbbVie reported a U.S. Complete Response Letter in April 2026. Its maintained regional record appears under botulinum toxin type E.
Product-Specific Reading Notes
Section titled “Product-Specific Reading Notes”Botox requires extra care because Botox and Botox Cosmetic have separate U.S. label contexts. The same nonproprietary name, onabotulinumtoxinA, does not collapse therapeutic and aesthetic indications into one universal claim. Botox Cosmetic also has aesthetic indications, such as forehead lines and platysma bands, that are not yet represented as separate indication pages in this index.
Myobloc is the represented type B product. Its cervical dystonia indication makes it visible beside type A therapeutic products, but serotype, potency units, dose language, and adverse-effect interpretation remain product-specific.
Dysport and Xeomin both have therapeutic and aesthetic U.S. label contexts. Xeomin’s aesthetic label now covers three upper-face areas, while Dysport’s aesthetic label remains specific to glabellar lines. Shared use areas such as cervical dystonia, spasticity, blepharospasm, or glabellar lines should be read through each product’s own label rather than as evidence of substitutability.
Jeuveau and Letybo are narrow U.S. aesthetic-label entries in the current graph. Their Korean manufacturing connections help explain market structure, but U.S. indication interpretation remains tied to the Jeuveau and Letybo labels rather than to regional portfolio names.
Daxxify combines an adult glabellar-line aesthetic indication with an adult cervical dystonia therapeutic indication. That broader U.S. label scope does not establish unit equivalence, duration superiority, or clinical preference over other products.
Related Approval Context
Section titled “Related Approval Context”Use this table to answer whether a represented product has a current U.S. labeled indication. Use the U.S. FDA approval timeline to understand when major U.S. approval anchors entered the record. Use indication pages for clinical context and safety framing for cautious interpretation, not as substitutes for current prescribing information.
Sources
Section titled “Sources”This matrix uses current prescribing information from FDA and DailyMed, the National Library of Medicine’s official label repository, as the primary source trail for U.S. labeled indications. Label materials were last checked on August 10, 2026. A DailyMed record-update date can be later than the prescribing information’s printed revision date, so both are identified where that distinction helps interpret the source. Labels can change, and current prescribing information remains the authority for approved uses, dosing language, warnings, preparation, and patient populations.