BOTOX COSMETIC
BOTOX Cosmetic (onabotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for use in adult patients. It is used for the temporary improvement in the appearance of moderate to severe glabellar lines, lateral canthal lines, forehead lines, and platysma bands. The treatment targets specific muscle activity in the face and neck, including the corrugator, procerus, orbicularis oculi, frontalis, and platysma muscles. By reducing localized muscle activity, the drug addresses aesthetic concerns related to these specific muscle groups.
How BOTOX COSMETIC Works
BOTOX Cosmetic blocks neuromuscular transmission by binding to motor nerve terminals and inhibiting the release of the neurotransmitter acetylcholine. The neurotoxin enters the nerve terminals and cleaves SNAP-25, a pre-synaptic protein required for the successful release of acetylcholine from vesicles. This inhibition results in partial chemical denervation and a localized reduction in muscle activity at the injection site. While the treatment causes temporary muscle relaxation, reinnervation of the muscle may eventually occur to reverse the denervation.
Details
- Status
- Prescription
- First Approved
- 1991-12-09
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
BOTOX COSMETIC Approval History
What BOTOX COSMETIC Treats
4 indicationsBOTOX COSMETIC is approved for 4 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glabellar Lines
- Lateral Canthal Lines
- Forehead Lines
- Platysma Bands
BOTOX COSMETIC Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be li...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses. [see Warnings and Precautions ( 5.2 )] WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. ( 5.2 )
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BOTOX COSMETIC FDA Label Details
ProIndications & Usage
FDA Label (PDF)BOTOX Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of: • moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity • moderate to severe lateral canthal lines associated with orbicularis oculi activity • moderate to severe forehead lines associated with frontalis muscle activity • moderate to severe platysma bands associated with platysma muscle activity BOTOX Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvemen...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplo...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.