Xeomin

Treats chronic sialorrhea. BLA 125360, held by Merz Pharms. incobotulinumtoxinA.

As of Nov 13, 2026, BLA 125360 (Xeomin), held by Merz Pharms, was first approved by FDA on Jul 30, 2010, with 24 approved supplements and 0 published complete response letters.

First approved: Jul 30, 2010
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older Upper limb spasticity in patients 2 years of age and older Cervical dystonia in adults Blepharospasm in adults the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines associated with frontalis muscle activity moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jun 25, 2026	Supplement 108Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 5, 2024	Supplement 99Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 18, 2020	Supplement 86Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 18, 2020	Supplement 78Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 10, 2019	Supplement 74Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 3, 2018	Supplement 73Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 22, 2015	Supplement 67Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 20, 2011	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label
Jul 30, 2010	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 30, 2010	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Xeomin50 UNITS/VIAL · injectable;injection	incobotulinumtoxinA	Rx
Xeomin100 UNITS/VIAL · injectable;injection	incobotulinumtoxinA	Rx
Xeomin200 UNITS/VIAL · injectable;injection	incobotulinumtoxinA	Rx

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 25, 2026	Supplement 108Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 20, 2026	Supplement 107Labeling · Standard review	Approved	Label Letter
Feb 26, 2026	Supplement 110Labeling · Standard review	Approved	Label Letter
Dec 17, 2025	Supplement 106Labeling · Standard review	Approved	Letter Label
Jul 5, 2024	Supplement 99Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 8, 2023	Supplement 97Labeling · Standard review	Approved	Label Letter
Aug 13, 2021	Supplement 93Labeling · Standard review	Approved	Label Letter
Apr 19, 2021	Supplement 91Labeling · Standard review	Approved	Letter Label
Apr 19, 2021	Supplement 90Labeling · Standard review	Approved	Letter Label
Apr 19, 2021	Supplement 89Labeling · Standard review	Approved	Letter Label
Apr 19, 2021	Supplement 88Labeling · Standard review	Approved	Letter Label
Apr 19, 2021	Supplement 87Labeling · Standard review	Approved	Letter Label
Dec 18, 2020	Supplement 92Labeling · Standard review	Approved	Letter Label
Dec 18, 2020	Supplement 86Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 18, 2020	Supplement 78Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 10, 2019	Supplement 74Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 3, 2018	Supplement 73Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 22, 2015	Supplement 67Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 20, 2015	Supplement 66Manufacturing	Approved	Label
Apr 11, 2013	Supplement 45Labeling · Standard review	Approved	Letter Label
Jul 16, 2012	Supplement 40Labeling · Standard review	Approved	Letter
Jul 20, 2011	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label
Jun 2, 2011	Supplement 12Labeling · Standard review	Approved	None posted
Jul 30, 2010	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 30, 2010	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: XeominOct 31, 2024

Identifiers

Application: BLA 125360
Drugs@FDA: Overview at FDA
Company: Merz Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters