birch triterpenes

FDA Drug Profile — FILSUVEZ

Drug Details

Generic Name
birch triterpenes
Brand Names
FILSUVEZ
Application Number
NDA215064
Sponsor
Amryt Pharmaceuticals DAC
NDC Codes
3
Dosage Forms
GEL
Routes
TOPICAL
Active Ingredients
BIRCH TRITERPENES

Indications and Usage

1 INDICATIONS AND USAGE FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older. ( 1 )