U.S. Botulinum Toxin Regulatory Status

U.S. botulinum toxin regulatory status falls into distinct stages. An FDA-approved product has an approval record and current prescribing information. A supplemental Biologics License Application (sBLA) seeks a change to an existing approval; acceptance for review does not authorize the proposed new use. A Biologics License Application (BLA) that receives a Complete Response Letter (CRL) is not approved in its submitted form. A company-announced submission or resubmission plan does not establish that FDA has accepted an application for review.

Seven botulinum toxin product families have FDA approval records: Botox / Botox Cosmetic, Myobloc, Dysport, Xeomin, Jeuveau, Daxxify, and Letybo. Botox and Botox Cosmetic share onabotulinumtoxinA but have separate therapeutic and aesthetic labels. Boey and Relfydess have public U.S. BLA histories but are not FDA approved. MT10109L has a reported U.S. filing and resubmission history, without an established U.S. approval or accepted resubmission in the public records cited below.

Regulatory stage is product-specific

FDA approval, application acceptance, a CRL, and a planned submission are different events. None establishes unit equivalence, interchangeability, clinical superiority, or approval in another market.

FDA-Approved Products

Product	Nonproprietary name	Original U.S. approval anchor	Current label context
Botox / Botox Cosmetic	OnabotulinumtoxinA	Therapeutic Botox entered the U.S. approval record in 1989; FDA approved Botox Cosmetic for glabellar lines on April 12, 2002 (FDA approval letter 🔗).	Separate therapeutic Botox 🔗 and Botox Cosmetic 🔗 labels define the current uses.
Myobloc	RimabotulinumtoxinB	FDA approved Myobloc for cervical dystonia on December 8, 2000 (FDA approval letter 🔗).	The current Myobloc label 🔗 covers its present therapeutic scope.
Dysport	AbobotulinumtoxinA	FDA approved the original Dysport BLA on April 29, 2009 (FDA approval letter 🔗).	The current Dysport label 🔗 defines its therapeutic and aesthetic uses.
Xeomin	IncobotulinumtoxinA	FDA approved Xeomin on July 30, 2010 (FDA approval letter 🔗).	FDA approved removal of the cerebral-palsy exclusion from the pediatric upper-limb-spasticity indication on June 25, 2026 (FDA supplement approval letter 🔗); the current Xeomin label 🔗 defines its full therapeutic and aesthetic scope.
Jeuveau	PrabotulinumtoxinA-xvfs	FDA approved Jeuveau on February 1, 2019 (FDA approval letter 🔗).	The current Jeuveau label 🔗 defines its adult glabellar-line use.
Daxxify	DaxibotulinumtoxinA-lanm	FDA approved Daxxify for glabellar lines on September 7, 2022 (FDA Drug Trials Snapshot 🔗).	The current Daxxify label 🔗 includes adult glabellar lines and cervical dystonia.
Letybo	LetibotulinumtoxinA-wlbg	FDA approved Letybo on February 29, 2024 (FDA Drug Trials Snapshot 🔗).	The current Letybo label 🔗 defines its adult glabellar-line use.

The U.S. FDA approval timeline preserves original approvals and selected indication expansions. The U.S. FDA indication matrix compares current product-specific label scope and patient limits.

Supplemental Application Under Review

Product / proposed indication	Public review milestone	Approval boundary
Botox Cosmetic / masseter muscle prominence	Allergan Aesthetics announced on August 4, 2026 that FDA had accepted an sBLA for temporary improvement in the appearance of marked to very marked masseter muscle prominence associated with masseter muscle activity in adults (company sBLA announcement 🔗).	The proposed use is under review, not an approved indication. The existing Botox Cosmetic label 🔗 covers glabellar, lateral canthal, and forehead lines, and platysma bands.

An approved product can have a proposed new indication under review. Its established approval does not extend to that proposed use.

Public BLA Outcomes Without U.S. Approval

Product / program	Public U.S. event	Current interpretation	Company-reported next step
Boey / trenibotulinumtoxinE	AbbVie reported an FDA CRL on April 23, 2026. The company said FDA requested additional manufacturing-process information and did not request additional clinical studies (AbbVie BLA update 🔗).	The BLA was not approved in its submitted form. Canadian and European Economic Area approvals do not create U.S. approval.	In the October 30, 2026 earnings call, management anticipated resubmission before year-end and a regulatory decision in mid-2027, according to the published AbbVie Q3 call transcript — The Motley Fool 🔗. These are company expectations, not a completed or accepted resubmission, an FDA-assigned decision date, or approval.
Relfydess / relabotulinumtoxinA	Galderma announced an FDA CRL on July 1, 2026; its October 22 update dates receipt to June 2026. The company described comments related to manufacturing-site inspection observations and analytical-method optimization (Galderma CRL announcement 🔗).	Relfydess is not FDA approved. Its international approvals and launches remain separate regional records.	On October 22, 2026, Galderma said it was targeting BLA resubmission in the first quarter of 2027, subject to further regulatory feedback (Galderma third-quarter 2026 update 🔗). This is a target, not a completed or accepted resubmission.

A CRL should not be rewritten as a permanent rejection or as evidence about comparative safety, efficacy, onset, duration, or product quality. The public explanations above are company descriptions of FDA feedback; they are not substitutes for an FDA approval record or prescribing information.

Resubmission Planning Before FDA Review

Product / program	Filing history	Current interpretation	Source context
MT10109L	Medytox submitted a BLA in December 2023. The application was not accepted for substantive review in February 2024 because of incomplete documentation. Subsequent reporting describes continued dossier preparation rather than an accepted resubmission.	MT10109L is not FDA approved and is not documented here as an application currently under FDA review. It remains a Medytox development and resubmission program rather than a U.S.-approved brand.	Medytox’s company history 🔗 records the 2023 filing. ChosunBiz reported on October 8, 2026 🔗 that documentation supplementation remained in its final stages, without a disclosed resubmission date. This is reporting, not an FDA acceptance record.

This section does not attempt to list every global toxin pipeline. It includes a pre-review program only when the U.S. filing history is public, the distinction is important to an existing company or product page, and the available source supports a precise regulatory stage.

What a Complete Response Letter Means

A Complete Response Letter (CRL) is FDA’s formal notice that it has completed a review cycle and cannot approve an application in its current form. It identifies deficiencies that must be addressed before approval. A CRL is neither approval nor conditional approval, and it does not necessarily mean that approval is permanently ruled out (FDA explanation of CRLs 🔗).

The reason matters: deficiencies may concern manufacturing, quality, clinical evidence, or other parts of the application. Receiving a CRL alone does not establish that a product is unsafe, ineffective, or inferior to another product. The sponsor may address the deficiencies and resubmit for another review cycle; a planned response, a submitted response, and an eventual approval are separate milestones (FDA CRL database and explanation 🔗).

For Boey and Relfydess, the product-specific dates, company descriptions of FDA feedback, and announced next steps appear in the public BLA outcomes table above. A company summary should be attributed to the company and distinguished from the FDA letter itself.

Regulatory Terms

Term	What it establishes
FDA approved	FDA has approved a specific application for a specific product and label. Current prescribing information controls the approved scope.
Application accepted for review	FDA has accepted the filing for substantive review. This is a review milestone, not approval.
Complete Response Letter	FDA has completed its review and will not approve the application in its present form. A sponsor may respond or resubmit.
Submission or resubmission planned	A company intends to file. It does not establish that FDA has received or accepted an application.
Application withdrawn	The sponsor has withdrawn the application or an authorization. The date, market, and scope must be stated from the controlling source.

Knowledge Check

1. What did Galderma's October 22, 2026 Relfydess update establish?

A. FDA accepted a new resubmission in October 2026.B. FDA approved the U.S. BLA after the CRL.C. The company targeted resubmission in the first quarter of 2027.D. FDA fixed a first-quarter 2027 approval date.

2. How can Botox Cosmetic be FDA approved while a masseter application is under review?

A. Acceptance automatically adds the proposed use to the label.B. Existing approved uses and a proposed additional use have distinct statuses.C. The review suspends the product's existing aesthetic approvals.D. Existing approval extends to related lower-face uses.

3. Which distinction applies to MT10109L's filing history?

A. A filing not accepted for review differs from a CRL after review.B. Its December 2023 submission establishes an accepted application.C. Reported dossier preparation establishes a completed resubmission.D. Its completed studies establish U.S. marketing approval.