Overview
The aesthetic utility of botulinum toxin was discovered incidentally following its initial use in the treatment of facial spasmodic disorders in the early 1970s. The first aesthetic use of botulinum toxin was reported in 1989, when onabotulinumtoxinA (Botox) was used as a treatment for facial asymmetry resulting from iatrogenic facial nerve damage. It was subsequently approved by the FDA in 1992 for use in aesthetic procedures and has since become one of the most popular cosmetic procedures worldwide. Letibotulinumtoxina is a type A botulinum neurotoxin produced from fermentation of Clostridium botulinum strain CBFC26. It is a 900 kDa multimeric complex comprising a 150 kDa toxin, a 130 kDa non-toxic non-haemagglutinating protein, and various other haemagglutinins. Letibotulinumtoxina has been a market-leading cosmetic product in South Korea for a number of years and was more recently approved in the European Union. It was approved for use in Canada in June 2022 for the treatment of glabellar lines.
Indication
Letibotulinumtoxina is indicated for the temporary improvement of the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients ≤65 years of age.
Associated Conditions
- Moderate to Severe Glabellar Frown Lines
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|
No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LETYBO (letibotulinumtoxinA) 100 U, Powder for injection | 370011 | Medicine | A | 11/28/2022 | |
| LETYBO (letibotulinumtoxinA) 50 U Powder for injection | 370012 | Medicine | A | 11/28/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.