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FDA Medication Tracker

← All approvals · Other · 2024

Letybo (letibotulinumtoxinA-wlbg)

The FDA approved Letybo (letibotulinumtoxinA-wlbg) on February 29, 2024 to temporarily improve the appearance of moderate-to-severe glabellar lines.
Brand name
Letybo
Generic name
letibotulinumtoxinA-wlbg
FDA approval date
February 29, 2024
Approved use (FDA wording)
To temporarily improve the appearance of moderate-to-severe glabellar lines
Company
Hugel Inc.
Application
BLA761225
Dosage form / route
POWDER, FOR SOLUTION
Drug class (EPC)
Acetylcholine Release Inhibitor [EPC]
Boxed warning on label
Yes (see the FDA label)
Category on this site
Other

Indications and usage, from the FDA label

LETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. LETYBO is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.