Xeomin® (incobotulinumtoxinA)

BL 125360

Xeomin® (incobotulinumtoxinA)

BL 125360

U.S. License Holder:

Merz Pharms.

Date of License:

July-30-2010

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

XEOMIN (incobotulinumtoxinA) 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 adults;

Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy;

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 activit; Moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity.

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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