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FDA BLA · BLA125360

XEOMIN

incobotulinumtoxina

Sponsor: MERZ PHARMS

APPLICATION
BLA125360
TYPE
BLA
ORIGINAL APPROVAL
2010-07-30
LATEST ACTION
2026-06-25
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

XeominPrescription
incobotulinumtoxinA 200 UNITS/VIAL · INJECTABLE · INJECTION
XeominPrescription
incobotulinumtoxinA 50 UNITS/VIAL · INJECTABLE · INJECTION
XeominPrescription
incobotulinumtoxinA 100 UNITS/VIAL · INJECTABLE · INJECTION

Approval history

2026-06-25Efficacy · Supplement 108 · standard — Letter ↗AP
2026-03-20Labeling · Supplement 107 · standard — Label ↗AP
2026-02-26Labeling · Supplement 110 · standard — Label ↗AP
2025-12-17Labeling · Supplement 106 · standard — Letter ↗AP
2024-07-05Efficacy · Supplement 99 · standardAP
2023-09-08Labeling · Supplement 97 · standard — Letter ↗AP
2021-08-13Labeling · Supplement 93 · standard — Letter ↗AP
2021-04-19Labeling · Supplement 89 · standard — Label ↗AP
2021-04-19Labeling · Supplement 87 · standard — Label ↗AP
2021-04-19Labeling · Supplement 91 · standard — Label ↗AP
2021-04-19Labeling · Supplement 88 · standard — Label ↗AP
2021-04-19Labeling · Supplement 90 · standard — Label ↗AP
2020-12-18Efficacy · Supplement 86 · priority — Label ↗AP
2020-12-18Labeling · Supplement 92 · standard — Label ↗AP
2020-08-18Efficacy · Supplement 78 · standard — Letter ↗AP
2019-05-10Efficacy · Supplement 74 · standard — Letter ↗AP
2018-07-03Efficacy · Supplement 73 · priority — Label ↗AP
2015-12-22Efficacy · Supplement 67 · standard — Label ↗AP
2015-11-20Manufacturing (CMC) · Supplement 66 — Label ↗AP
2013-04-11Labeling · Supplement 45 · standard — Letter ↗AP
2012-07-16Labeling · Supplement 40 · standard — Letter ↗AP
2011-07-20Efficacy · Supplement 7 · standard — Label ↗AP
2011-06-02Labeling · Supplement 12 · standardAP
2010-07-30Efficacy · Supplement 1 · standard — Label ↗AP
2010-07-30Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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