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Xeomin FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved July 30, 2010)
Brand name: Xeomin
Generic name: incobotulinumtoxinA
Dosage form: Injection
Company: Merz Pharmaceuticals
Treatment for: Cervical Dystonia, Blepharospasm, Facial Wrinkles, Upper Limb Spasticity, Excessive Salivation

Xeomin (incobotulinumtoxinA) is a botulinum toxin type A for the treatment of cervical dystonia, blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.

Development Timeline for Xeomin

Dec 21, 2020Approval  FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea
May 14, 2019Approval  FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients
Jul  3, 2018Approval  FDA Approves Xeomin (incobotulinumtoxinA) for Adult Patients with Sialorrhea (Excessive Drooling)
Dec 23, 2015Approval  Merz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for Treatment of Adult Upper Limb Spasticity
Jul 21, 2011Approval  Merz Aesthetics Announces FDA Approval Of Xeomin (incobotulinumtoxinA) For The Temporary Improvement In The Appearance Of Moderate To Severe Glabellar Lines In Adult Patients
Aug  2, 2010Approval  FDA Approves Merz Pharmaceuticals' Xeomin (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm

Further information

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