incobotulinumtoxinA
incobotulinumtoxinA is listed in the FDA National Drug Code directory with 21 NDC codes, marketed under brand name including Xeomin. Available dosage form: injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- incobotulinumtoxinA
- Brand Names
- Xeomin
- Application Number
- BLA125360
- Sponsor
- Merz Pharmaceuticals, LLC
- NDC Codes
- 21
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAMUSCULAR
- Active Ingredients
- BOTULINUM TOXIN TYPE A
Indications and Usage
1 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 ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity ( 1.5 ) moderate to severe horizontal forehead lines associated with frontalis muscle activity ( 1.5 ) moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity ( 1.5 ) 1.1 Chronic Sialorrhea XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. 1.2 Upper Limb Spasticity XEOMIN is indicated for the treatment of upper limb spasticity in patients 2 years of age and older. 1.3 Cervical Dystonia XEOMIN is indicated for the treatment of cervical dystonia in adult patients. 1.4 Blepharospasm XEOMIN is indicated for the treatment of blepharospasm in adult patients. 1.5 Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) XEOMIN is indicated in adult patients for the temporary improvement in the appearance of upper facial lines: moderate to severe glabellar lines (GL) associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines (HFL) associated with frontalis muscle activity moderate to severe lateral canthal lines (LCL) associated with orbicularis oculi muscle activity.